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Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea (DOSA)

Primary Purpose

Down Syndrome, Obstructive Sleep Apnea

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxygen
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

5 Years - 215 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 5.0 to 17.9 years at the time of screening Children with Obstructive Sleep Apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40/hour. : Absence of clinically significant hypoxia defined as oxygen saturation <88% for 5 minutes or episodic desaturation to 60%. Favorable response to oxygen therapy (allowing randomization) will be defined as follows: Oxygen saturation nadir >92% and Decrease in obstructive index < 5 / hour or by > 50% from screening PSG Reaching an optimum oxygen flow, which is defined as the flow that achieves the lowest level of AHI without hypoventilation. Oxygen flow required does not exceed 3.0 liter/minute or Fraction of Inspired Oxygen (FiO2) >40%. Willingness to comply with all study procedures and be available for the duration of study. At baseline, the participant attempts to perform the neuropsychological tests Exclusion Criteria: Current CPAP use with documented compliance(> 4 hrs/ night; > 70% of nights). Oxygen saturation < 90% at rest during wakefulness. Chronic daytime or nighttime use of supplemental oxygen. Smoker in the child's bedroom. Unrepaired congenital heart disease. Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator. Unable to participate in a PSG. Individuals who develop alveolar hypoventilation with oxygen as previously defined. Other severe chronic diseases determined by their provider as making them poor study candidates. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial. Documented clinically significant untreated hypothyroidism Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.

Sites / Locations

  • Children's Hospital of Los Angeles
  • University of Michigan, Ann Arbor Hospital
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Children's Hospital, Case Medical Center
  • Children's Hospital of Philadelphia
  • East Virginia Medical Center
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Oxygen plus supportive care (OXT)

Supportive care (SC)

Arm Description

Nocturnal oxygen therapy plus providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.

Providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.

Outcomes

Primary Outcome Measures

Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score
Change from baseline in the Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score (BRIEF2wm). The score ranges from 35-90. A higher score is a worse outcome.
Differential Ability Scales - 2nd Edition (DAS-II) T-score.
Change from baseline in the Differential Ability Scales - 2nd Edition (DAS-II) recognition of pictures (DAS2RoP) T-score. The score ranges from 10-90. A higher score is a better outcome.

Secondary Outcome Measures

Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score. The score ranges from 0-64. A higher score is a better outcome.
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score. The score ranges from 0-30. A higher score is a better outcome.
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score. The score ranges from 0-34. A higher score is a better outcome.
Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score
Change from baseline in Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score. The score ranges from 0-38. A higher score is a better outcome.
Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) adjusted total errors based on stages completed
Change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) adjusted total errors based on stages completed
Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI)
Change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI)
Developmental Neuropsychological Assessment 2nd Edition (NEPSY-II) verbal fluency test raw score
Change from baseline in Developmental Neuropsychological Assessment 2nd Edition (NEPSY-II) verbal fluency test raw score. Range-N/A
Observer Memory Questionnaire - Parent Form (OMQ-PF) total T-score
Change from baseline in Observer Memory Questionnaire - Parent Form (OMQ-PF) total T-score. The score ranges from 0-135. A higher score is a better outcome.
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for subscales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate)
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for subscales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate).
Child Behavior Checklist (CBCL) T-scores for domains (Internalizing, Externalizing, Total Problems).
Change from baseline in Child Behavior Checklist (CBCL) T-scores for domains (Internalizing, Externalizing, Total Problems).
Child Behavior Checklist (CBCL) T-scores for subscales (Attention Problems, Thought Problems, Rule-Breaking Behaviors, Aggressive Behaviors)
Change from baseline in Child Behavior Checklist (CBCL) T-scores for subscales (Attention Problems, Thought Problems, Rule-Breaking Behaviors, Aggressive Behaviors)
KIDSCREEN-27 T-score
Change from baseline in KIDSCREEN-27 T-score, including domains of: physical well-being; psychological well-being; autonomy and parent relations; social support and peers; school environment. Range-N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance T-score
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance T-score. The score ranges from 28.7-85.6. A higher score is a worse outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score. The score ranges from 37.9-86.6. A higher score is a worse outcome.
Presence of right ventricular hypertension
Presence of right ventricular hypertension as measured by tricuspid regurgitation continuous wave peak velocity (defined as a ratio of pulmonary artery pressure / systolic arterial pressure (PAP/SAP) >1/3); interventricular septal flattening as measured by eccentricity index (defined as systolic ratio of >1.25)
Wechsler Intelligence Scale (WISC) for Children 5th edition (WISC-5) Cancellation raw score
Change from baseline of Wechsler Intelligence Scale (WISC) for Children 5th edition (WISC-5) Cancellation raw score. The score ranges from 0-128. A higher score is a better outcome.
Wechsler Preschool and Primary Scale of Intelligence 4th edition (WPPSI-4) Cancellation task raw score
Change from baseline in Wechsler Preschool and Primary Scale of Intelligence 4th edition (WPPSI-4) Cancellation task raw score (if unable to complete Wechsler Intelligence Scale 5th edition Cancellation test). The score ranges from 0-96. A higher score is a better outcome.
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Behavior Regulation Index (BRI) domain.
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Behavior Regulation Index (BRI) domain. The score ranges from 35-90. A higher score is a worse outcome.
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Emotional Recognition Index (ERI) domain.
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Emotional Recognition Index (ERI) domain. The score ranges from 35-90. A higher score is a worse outcome.
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Cognitive Regulation Index (CRI) domain.
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Cognitive Regulation Index (CRI) domain. The score ranges from 35-90. A higher score is a worse outcome.
7-day actigraphy measurement of sleep efficiency
Change from baseline in 7-day actigraphy measurement of sleep efficiency
7-day actigraphy measurement of time wake after sleep onset
Change from baseline in 7-day actigraphy measurement of time wake after sleep onset
7-day actigraphy measurement of sleep fragmentation
Change from baseline in 7-day actigraphy measurement of sleep fragmentation
7-day actigraphy measurement of total sleep duration
Change from baseline in 7-day actigraphy measurement of total sleep duration
Polysomnography (PSG) AHI parameter
Change from baseline in Polysomnography (PSG) AHI parameter. The score ranges from 0- >40. A higher score is a worse outcome.
Polysomnography (PSG) percentage time of O2 <90 % parameter
Change from baseline in Polysomnography (PSG) percentage time of O2 <90 % parameter
Polysomnography (PSG) sleep apnea associated hypoxic burden parameter
Change from baseline in Polysomnography (PSG) sleep apnea associated hypoxic burden, parameter
Polysomnography (PSG) end-tidal CO2 level, parameter
Change from baseline in Polysomnography (PSG) end-tidal CO2 parameter.
Polysomnography (PSG) -based measure of sleep stages
Change from baseline in Polysomnography (PSG) -based measure of sleep stages. Range- N/A
Polysomnography (PSG) -based measure of EEG power bands
Change from baseline in Polysomnography (PSG) -based measure of EEG power bands
Polysomnography (PSG) -based measure of spindle morphology
Change from baseline in Polysomnography (PSG) -based measure of spindle morphology
Polysomnography (PSG) -based measure of spindle numbers
Change from baseline in Polysomnography (PSG) -based measure of spindle numbers
Polysomnography (PSG) -based measure of spindle density
Change from baseline in Polysomnography (PSG) -based measure of spindle density
Polysomnography (PSG) -based measure of slow wave oscillations
Change from baseline in Polysomnography (PSG) -based measure of slow wave oscillations
Left ventricular diastolic function as measured by Mitral E and A wave (E:A ratio)
Change from baseline in left ventricular diastolic function as measured by Mitral E and A wave (E:A ratio)
Left ventricular diastolic function as measured by E wave deceleration time
Change from baseline in left ventricular diastolic function as measured by E wave deceleration time
Left ventricular diastolic function as measured by Mitral septal and lateral e' and a' (E/e')
Change from baseline in left ventricular diastolic function as measured by Mitral septal and lateral e' and a' (E/e')
Left ventricular diastolic function as measured by Mitral lateral tissue Doppler isovolumic relaxation time
Change from baseline in left ventricular diastolic function as measured by Mitral lateral tissue Doppler isovolumic relaxation time
Left ventricular diastolic function as measured by Pulmonary vein A wave reversal duration
Change from baseline in left ventricular diastolic function as measured by Pulmonary vein A wave reversal duration
Left ventricular diastolic function as measured by Left atrial volume
Change from baseline in left ventricular diastolic function as measured by Left atrial volume

Full Information

First Posted
August 17, 2023
Last Updated
September 25, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Rainbow Babies and Children's Hospital, University of Michigan, Children's Hospital Los Angeles, Children's Hospital of The King's Daughters, Seattle Children's Hospital, University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT06043440
Brief Title
Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea
Acronym
DOSA
Official Title
Randomized Control Trial of Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 27, 2023 (Anticipated)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
December 27, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Rainbow Babies and Children's Hospital, University of Michigan, Children's Hospital Los Angeles, Children's Hospital of The King's Daughters, Seattle Children's Hospital, University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).
Detailed Description
This will be a randomized, single-blind 6-month Phase-2 clinical trial that compares the impact of oxygen therapy during sleep on measures of cognition, behavior, quality of life, cardiac structure and function, and sleep in children with Down Syndrome(DS) with moderate to severe obstructive sleep apnea. The proposed study will involve participation of children and their caregivers. Children will be recruited from each site's sleep clinics and laboratories, Down syndrome clinics and otolaryngology clinics. Community recruitment will be coordinated with local Down Syndrome Associations. Children who agree to participate in the study will be screened for eligibility based on history, physical examination, and review of medical records including history of congenital heart disease and Pulmonary Hypertension (PHTN), and use of Continuous Positive Airway Pressure (CPAP). Children eligible for the study are those with persistent obstructive apnea after adenotonsillectomy or children with obstructive sleep apnea without adenotonsillar hypertrophy or in situations when parents refuse adenotonsillectomy.. The enrollment PSG eligibility will be determined by central scoring of either a research Polysomnography (PSG). In addition to an oxygen titration PSG, which determines responsiveness to oxygen, participants will be asked to wear a wrist actigraph and undergo neurocognitive testing, echocardiography, physical examination, anthropometry, and venipuncture. Caregivers will complete questionnaires to assess their child's emotional, physical, social, and school functioning, sleep quality; child's behavior and cognitive function, and will complete a sleep diary that is used concurrently with their child's use of a wrist actigraph. The latter includes caregiver completion of the "Behavior Rating Inventory of Executive Function" (BRIEF2), a co-primary outcome. At 3 months, caregivers will complete the BRIEF2. At 6 months, all baseline studies and a PSG will be repeated. At baseline, demographic data will be collected, including information on residential address (for use in geocoding).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxygen plus supportive care (OXT)
Arm Type
Active Comparator
Arm Description
Nocturnal oxygen therapy plus providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.
Arm Title
Supportive care (SC)
Arm Type
No Intervention
Arm Description
Providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
Active nocturnal oxygen concentrator
Primary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score
Description
Change from baseline in the Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score (BRIEF2wm). The score ranges from 35-90. A higher score is a worse outcome.
Time Frame
Baseline and 6 months
Title
Differential Ability Scales - 2nd Edition (DAS-II) T-score.
Description
Change from baseline in the Differential Ability Scales - 2nd Edition (DAS-II) recognition of pictures (DAS2RoP) T-score. The score ranges from 10-90. A higher score is a better outcome.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score
Description
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score. The score ranges from 0-64. A higher score is a better outcome.
Time Frame
Baseline and 6 Months
Title
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score
Description
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score. The score ranges from 0-30. A higher score is a better outcome.
Time Frame
Baseline and 6 Months
Title
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score
Description
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score. The score ranges from 0-34. A higher score is a better outcome.
Time Frame
Baseline and 6 Months
Title
Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score
Description
Change from baseline in Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score. The score ranges from 0-38. A higher score is a better outcome.
Time Frame
Baseline and 6 Months
Title
Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) adjusted total errors based on stages completed
Description
Change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) adjusted total errors based on stages completed
Time Frame
Baseline and 6 Months
Title
Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI)
Description
Change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI)
Time Frame
Baseline and 6 Months
Title
Developmental Neuropsychological Assessment 2nd Edition (NEPSY-II) verbal fluency test raw score
Description
Change from baseline in Developmental Neuropsychological Assessment 2nd Edition (NEPSY-II) verbal fluency test raw score. Range-N/A
Time Frame
Baseline and 6 Months
Title
Observer Memory Questionnaire - Parent Form (OMQ-PF) total T-score
Description
Change from baseline in Observer Memory Questionnaire - Parent Form (OMQ-PF) total T-score. The score ranges from 0-135. A higher score is a better outcome.
Time Frame
Baseline and 6 Months
Title
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for subscales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate)
Description
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for subscales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate).
Time Frame
Baseline and 6 Months
Title
Child Behavior Checklist (CBCL) T-scores for domains (Internalizing, Externalizing, Total Problems).
Description
Change from baseline in Child Behavior Checklist (CBCL) T-scores for domains (Internalizing, Externalizing, Total Problems).
Time Frame
Baseline and 6 Months
Title
Child Behavior Checklist (CBCL) T-scores for subscales (Attention Problems, Thought Problems, Rule-Breaking Behaviors, Aggressive Behaviors)
Description
Change from baseline in Child Behavior Checklist (CBCL) T-scores for subscales (Attention Problems, Thought Problems, Rule-Breaking Behaviors, Aggressive Behaviors)
Time Frame
Baseline and 6 Months
Title
KIDSCREEN-27 T-score
Description
Change from baseline in KIDSCREEN-27 T-score, including domains of: physical well-being; psychological well-being; autonomy and parent relations; social support and peers; school environment. Range-N/A
Time Frame
Baseline and 6 Months
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance T-score
Description
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance T-score. The score ranges from 28.7-85.6. A higher score is a worse outcome.
Time Frame
Baseline and 6 Months
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score
Description
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score. The score ranges from 37.9-86.6. A higher score is a worse outcome.
Time Frame
Baseline and 6 Months
Title
Presence of right ventricular hypertension
Description
Presence of right ventricular hypertension as measured by tricuspid regurgitation continuous wave peak velocity (defined as a ratio of pulmonary artery pressure / systolic arterial pressure (PAP/SAP) >1/3); interventricular septal flattening as measured by eccentricity index (defined as systolic ratio of >1.25)
Time Frame
Baseline and 6 Months
Title
Wechsler Intelligence Scale (WISC) for Children 5th edition (WISC-5) Cancellation raw score
Description
Change from baseline of Wechsler Intelligence Scale (WISC) for Children 5th edition (WISC-5) Cancellation raw score. The score ranges from 0-128. A higher score is a better outcome.
Time Frame
Baseline and 6 Months
Title
Wechsler Preschool and Primary Scale of Intelligence 4th edition (WPPSI-4) Cancellation task raw score
Description
Change from baseline in Wechsler Preschool and Primary Scale of Intelligence 4th edition (WPPSI-4) Cancellation task raw score (if unable to complete Wechsler Intelligence Scale 5th edition Cancellation test). The score ranges from 0-96. A higher score is a better outcome.
Time Frame
Baseline and 6 Months
Title
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Behavior Regulation Index (BRI) domain.
Description
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Behavior Regulation Index (BRI) domain. The score ranges from 35-90. A higher score is a worse outcome.
Time Frame
Baseline and 6 Months
Title
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Emotional Recognition Index (ERI) domain.
Description
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Emotional Recognition Index (ERI) domain. The score ranges from 35-90. A higher score is a worse outcome.
Time Frame
Baseline and 6 Months
Title
Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Cognitive Regulation Index (CRI) domain.
Description
Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Cognitive Regulation Index (CRI) domain. The score ranges from 35-90. A higher score is a worse outcome.
Time Frame
Baseline and 6 Months
Title
7-day actigraphy measurement of sleep efficiency
Description
Change from baseline in 7-day actigraphy measurement of sleep efficiency
Time Frame
Baseline and 6 Months
Title
7-day actigraphy measurement of time wake after sleep onset
Description
Change from baseline in 7-day actigraphy measurement of time wake after sleep onset
Time Frame
Baseline and 6 Months
Title
7-day actigraphy measurement of sleep fragmentation
Description
Change from baseline in 7-day actigraphy measurement of sleep fragmentation
Time Frame
Baseline and 6 Months
Title
7-day actigraphy measurement of total sleep duration
Description
Change from baseline in 7-day actigraphy measurement of total sleep duration
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) AHI parameter
Description
Change from baseline in Polysomnography (PSG) AHI parameter. The score ranges from 0- >40. A higher score is a worse outcome.
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) percentage time of O2 <90 % parameter
Description
Change from baseline in Polysomnography (PSG) percentage time of O2 <90 % parameter
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) sleep apnea associated hypoxic burden parameter
Description
Change from baseline in Polysomnography (PSG) sleep apnea associated hypoxic burden, parameter
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) end-tidal CO2 level, parameter
Description
Change from baseline in Polysomnography (PSG) end-tidal CO2 parameter.
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) -based measure of sleep stages
Description
Change from baseline in Polysomnography (PSG) -based measure of sleep stages. Range- N/A
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) -based measure of EEG power bands
Description
Change from baseline in Polysomnography (PSG) -based measure of EEG power bands
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) -based measure of spindle morphology
Description
Change from baseline in Polysomnography (PSG) -based measure of spindle morphology
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) -based measure of spindle numbers
Description
Change from baseline in Polysomnography (PSG) -based measure of spindle numbers
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) -based measure of spindle density
Description
Change from baseline in Polysomnography (PSG) -based measure of spindle density
Time Frame
Baseline and 6 Months
Title
Polysomnography (PSG) -based measure of slow wave oscillations
Description
Change from baseline in Polysomnography (PSG) -based measure of slow wave oscillations
Time Frame
Baseline and 6 Months
Title
Left ventricular diastolic function as measured by Mitral E and A wave (E:A ratio)
Description
Change from baseline in left ventricular diastolic function as measured by Mitral E and A wave (E:A ratio)
Time Frame
Baseline and 6 Months
Title
Left ventricular diastolic function as measured by E wave deceleration time
Description
Change from baseline in left ventricular diastolic function as measured by E wave deceleration time
Time Frame
Baseline and 6 Months
Title
Left ventricular diastolic function as measured by Mitral septal and lateral e' and a' (E/e')
Description
Change from baseline in left ventricular diastolic function as measured by Mitral septal and lateral e' and a' (E/e')
Time Frame
Baseline and 6 Months
Title
Left ventricular diastolic function as measured by Mitral lateral tissue Doppler isovolumic relaxation time
Description
Change from baseline in left ventricular diastolic function as measured by Mitral lateral tissue Doppler isovolumic relaxation time
Time Frame
Baseline and 6 Months
Title
Left ventricular diastolic function as measured by Pulmonary vein A wave reversal duration
Description
Change from baseline in left ventricular diastolic function as measured by Pulmonary vein A wave reversal duration
Time Frame
Baseline and 6 Months
Title
Left ventricular diastolic function as measured by Left atrial volume
Description
Change from baseline in left ventricular diastolic function as measured by Left atrial volume
Time Frame
Baseline and 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
215 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 5.0 to 17.9 years at the time of screening Children with Obstructive Sleep Apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40/hour. : Absence of clinically significant hypoxia defined as oxygen saturation <88% for 5 minutes or episodic desaturation to 60%. Favorable response to oxygen therapy (allowing randomization) will be defined as follows: Oxygen saturation nadir >92% and Decrease in obstructive index < 5 / hour or by > 50% from screening PSG Reaching an optimum oxygen flow, which is defined as the flow that achieves the lowest level of AHI without hypoventilation. Oxygen flow required does not exceed 3.0 liter/minute or Fraction of Inspired Oxygen (FiO2) >40%. Willingness to comply with all study procedures and be available for the duration of study. At baseline, the participant attempts to perform the neuropsychological tests Exclusion Criteria: Current CPAP use with documented compliance(> 4 hrs/ night; > 70% of nights). Oxygen saturation < 90% at rest during wakefulness. Chronic daytime or nighttime use of supplemental oxygen. Smoker in the child's bedroom. Unrepaired congenital heart disease. Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator. Unable to participate in a PSG. Individuals who develop alveolar hypoventilation with oxygen as previously defined. Other severe chronic diseases determined by their provider as making them poor study candidates. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial. Documented clinically significant untreated hypothyroidism Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oltion Sina
Phone
8573407909
Email
osina@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Suzie Hicks
Phone
5136364944
Email
suzanna.hicks@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Redline
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raouf Amin
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Del Cid-Linare
Email
ddelcidlinares@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Sally Ward, MD
Facility Name
University of Michigan, Ann Arbor Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Herreshoff
Email
egalopin@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Ronald Chervin, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanna Hicks
Email
suzanna.hicks@cchmc.org
First Name & Middle Initial & Last Name & Degree
Raouf Amin, MD
Facility Name
Rainbow Babies and Children's Hospital, Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Keller
Email
Alyssa.Keller@Uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Sally Ibrahim, MD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebereh Uwah
Email
uwahe@chop.edu
First Name & Middle Initial & Last Name & Degree
Christopher Cielo, MD
Facility Name
East Virginia Medical Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Boswick
Email
BoswicST@EVMS.edu
First Name & Middle Initial & Last Name & Degree
Cristina Baldassari, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon McNamara
Email
sharon.mcnamara@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Maida Chen, MD

12. IPD Sharing Statement

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Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea

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