Back to resultsSelf-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Primary Purpose
Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Supporting Nasopharyngeal Airway (ssNPA)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypertonia, Muscle, Apnea, Respiration Disorders, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Neuromuscular Manifestations, Neurologic Manifestations
Eligibility Criteria
Inclusion Criteria:
- Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index [AHI]>10 or AHI>5 with nocturnal hypoxemia defined as oxygen saturation [SpO2] nadir <=75%).
- All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
- Post adenotonsillectomy or those with contraindications to tonsillectomy.
- Tonsil size 2+ or smaller.
- Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.
Exclusion Criteria:
- AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI<5 with hypoxemia.
- Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
- Active Coronavirus (COVID) 19 infections
- End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time on PSG
- Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.
- Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
- Moderate/severe tracheobronchomalacia
- Need for anticoagulative therapy
- Bleeding disorder
- Restrictive thoracic disorders
Sites / Locations
- The University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-Supporting Nasopharyngeal Airway (ssNPA)
Standard of Care
Arm Description
Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.
Outcomes
Primary Outcome Measures
Apnea-hypopnea index (AHI)
Measured during the polysomnogram
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
Measured by self report. Likert scale 0-5 (higher score is better)
Secondary Outcome Measures
Sleep quality
Higher score in parent report of sleep quality on scale 0-5 (higher score is better)
Snoring frequency
As reported by participant/care taker in survey given daily. Snoring frequency is rated on a Likert scale 1-5 where 5 indicates snoring more frequently.
Daytime sleepiness
Measured using the children's Epworth Sleepiness Scale - The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score).
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
There are several dimensions of the PedsQL: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each domain will be scored on a scale of 0 (never have problems) to 4 (almost always have problems) and transformed on a scale of 0-100 by reverse scoring (0=100, 1=75, 2=50, 3=25, 4=0). Psychosocial Health Summary Score is the sum of the items over the number of items answered in the Emotional, Social, and School Functioning scales. Physical Health Summary Score is the Physical Functioning Scale Score. The total QL score is the sum of all the items over the number of items answered on all scales.
Full Information
NCT ID
NCT05527652
First Posted
August 31, 2022
Last Updated
November 10, 2022
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05527652
Brief Title
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Official Title
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction, Tolerance, Trisomy 21, Down Syndrome
Keywords
Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypertonia, Muscle, Apnea, Respiration Disorders, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Neuromuscular Manifestations, Neurologic Manifestations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients will be randomized 1:1 to receive (1) immediate therapy with the ssNPA device or (2) a waitlisted control group who will receive standard of care (SoC) for the first 8 weeks and then be offered the ssNPA at week 8 for the rest of the study period (till week 16).
Masking
InvestigatorOutcomes Assessor
Masking Description
Aggregate and stratified outcomes will be revealed only to the unblinded statisticians with a firewall related to outcomes between statistician and investigators. Dr. Zopf will be blinded to all aggregate/stratified outcomes and Dr. O'Brien will be blinded to polysomnography and quality of life outcomes.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-Supporting Nasopharyngeal Airway (ssNPA)
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.
Intervention Type
Device
Intervention Name(s)
Self-Supporting Nasopharyngeal Airway (ssNPA)
Intervention Description
The ssNPA device is made of a single piece of flexible, medical-grade silicone. It is inserted through one nostril and extends to the anatomic position bypassing the upper airway obstruction above the epiglottis.
Primary Outcome Measure Information:
Title
Apnea-hypopnea index (AHI)
Description
Measured during the polysomnogram
Time Frame
Up to 16 weeks
Title
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
Description
Measured by self report. Likert scale 0-5 (higher score is better)
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Higher score in parent report of sleep quality on scale 0-5 (higher score is better)
Time Frame
Up to 16 weeks
Title
Snoring frequency
Description
As reported by participant/care taker in survey given daily. Snoring frequency is rated on a Likert scale 1-5 where 5 indicates snoring more frequently.
Time Frame
Up to 16 weeks
Title
Daytime sleepiness
Description
Measured using the children's Epworth Sleepiness Scale - The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score).
Time Frame
Up to 16 weeks
Title
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
Description
There are several dimensions of the PedsQL: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each domain will be scored on a scale of 0 (never have problems) to 4 (almost always have problems) and transformed on a scale of 0-100 by reverse scoring (0=100, 1=75, 2=50, 3=25, 4=0). Psychosocial Health Summary Score is the sum of the items over the number of items answered in the Emotional, Social, and School Functioning scales. Physical Health Summary Score is the Physical Functioning Scale Score. The total QL score is the sum of all the items over the number of items answered on all scales.
Time Frame
Up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index [AHI]>10 or AHI>5 with nocturnal hypoxemia defined as oxygen saturation [SpO2] nadir <=75%).
All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
Post adenotonsillectomy or those with contraindications to tonsillectomy.
Tonsil size 2+ or smaller.
Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.
Exclusion Criteria:
AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI<5 with hypoxemia.
Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
Active Coronavirus (COVID) 19 infections
End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time on PSG
Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.
Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
Moderate/severe tracheobronchomalacia
Need for anticoagulative therapy
Bleeding disorder
Restrictive thoracic disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Zopf, MD
Phone
734-233-4122
Email
davidzop@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Louise O'Brien, PhD
Phone
7342722783
Email
louiseo@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zopf, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zopf, MD
Phone
734-233-4122
Email
davidzop@med.umich.edu
First Name & Middle Initial & Last Name & Degree
David Zopf, MD
First Name & Middle Initial & Last Name & Degree
Louise O'Brien, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
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