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Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults (TRSPed)

Primary Purpose

Sleep-disordered Breathing (SDB)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleep study
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep-disordered Breathing (SDB) focused on measuring Sleep-disordered breathing (SDB), Poly(somno)graphy (P(S)G), Cerebral oxygenation, Cyclic alternating pattern (CAP), Psychological and neuropsychological tests, Screening questionnaires, Treatment of SDB

Eligibility Criteria

1 Year - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 1 to 20 years with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study
  • Written informed consent

Exclusion Criteria:

  • No social insurance
  • Significant psychomotor retardation
  • Cooperation not possible
  • Significant agitation
  • Acute condition and/or temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection)
  • Patient under guardianship/curatorship

Sites / Locations

  • Hôpital Necker-Enfants MaladesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep-disordered breathing (SDB)

Arm Description

Patients aged 1 to 20 years old with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study for their clinical care.

Outcomes

Primary Outcome Measures

Anxiety
Anxiety questionnaire using the Revised Children's Manifest Anxiety Scale (RCMAS), with an anxiety being defined by a total T-score ≥60. Mean normal value of T-score is 50 ± 10.
Depression
Depression questionnaire using the Multiscore Depression Inventory for Children (MDI-C), with an abnormal score being defined by a T-score ≥70. Mean normal value of T-score is 50 ± 10.
Quality of life
Quality of life questionnaire using the Pediatric Quality of Life Inventory (PedsQL). The higher the score, the better the quality of life. Min value = 0. Max value = 100.
Sensoriality
Sensoriality using the Sensory profile test. Atypical performance for a raw score <122. Min value = 38. Max value = 190.
NEPSY-II memory evaluation
Memory evaluation using the NEPSY-II test. Mean normal score is 10 ± 3. Abnormal for a score <4.
Children Memory Scale
Memory evaluation using the Children Memory Scale test. Mean normal score is 10 ± 3. Abnormal for a score <4.
Attention
Attention evaluation using the TAP test. Abnormal for a T-score <30. Mean normal value of T-score is 50 ± 10.
NEPSY-II score
Executive function evaluation using the NEPSY-II. Mean normal score tests is 10 ± 3, abnormal for a score <4.
Trail Making test score
Executive function evaluation using the Trail Making test. Mean normal score is 10 ± 3, abnormal for a score <4.
KiTAP subtests score
Executive function evaluation using the KiTAP subtests. Abnormal T-score <30, with mean normal value of T-score is 50 ± 10.
Behavior
Behavior evaluation using the Child Behaviour Checklist (CBCL). Abnormal T-score >65. Mean normal value of T-score is 50 ± 10.
Griffiths-III score
Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score <70.
WPPSI-IV score
Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score <70.
WISC-V score
Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score <70.
Language
Language evaluation using the Griffiths-III test. Mean normal score is 100 ± 15. Abnormal for a score <70.

Secondary Outcome Measures

Sleep disturbance
Score of the sleep disturbance scale for children (SDSC) to detect the presence and severity of SDB Children < 4 years old: Min value 3, max value 15. Abnormal if score >4. Children > 4 years old: Min value 5, max value 25. Abnormal if score >12.
3D facial surface analysis
Geometric morphometric approach based on 3D facial surface analysis of linear distances between 25 pairs of craniofacial landmarks, defined as direct Euclidean distance (in mm) between the two points.
3D facial surface analysis
Geometric morphometric approach based on 3D facial surface analysis of geodesic distances between 25 pairs of craniofacial landmarks, defined as the shortest distance (in mm) between two points when following the contour of the face/skin.
3D facial surface analysis
Geometric morphometric approach based on 3D facial surface analysis of angular measurements between 25 pairs of craniofacial landmarks, defined as the angles (in degree) between sets of three landmarks.
Changing detection of respiratory events
Comparison between the apnea-hypopnea index (AHI) obtained from the P(S)G and the AHI calculated using respiratory muscle EMG
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account hypoventilation and flow limitation
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account autonomic arousals using the pulse wave amplitude
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated using the pulse transit time
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated using mandibular movements
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated using cerebral oxygenation desaturations
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and respiratory muscles power by EMG.
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and hypoventilation and flow limitation scores by P(S)G.
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and autonomic arousals using pulse wave amplitude by pulse oximetry.
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and pulse transit time analysis by ECG.
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and mandibular movement analysis by non-invasive magnetic distance sensors.
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and cerebral oxygenation analysis by near-infrared spectroscopy.
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and the type of CAP by EEG.
Correlations with pulse oximetry
Correlation between pulse oximetry and respiratory muscles power by EMG.
Correlations with pulse oximetry
Correlation between pulse oximetry and hypoventilation and flow limitation scores by P(S)G.
Correlations with pulse oximetry
Correlation between pulse oximetry and autonomic arousals using pulse wave amplitude.
Correlations with pulse oximetry
Correlation between pulse oximetry and pulse transit time analysis.
Correlations with pulse oximetry
Correlation between pulse oximetry and mandibular movement analysis by non-invasive magnetic distance sensors.
Correlations with pulse oximetry
Correlation between pulse oximetry and cerebral oxygenation analysis by near-infrared spectroscopy.
Correlations with pulse oximetry
Correlation between pulse oximetry and the type of CAP.
Correlations with sleep questionnaires
Correlation between sleep questionnaires and respiratory muscles EMG.
Correlations with sleep questionnaires
Correlation between sleep questionnaires and hypoventilation and flow limitation scores by P(S)G.
Correlations with sleep questionnaires
Correlation between sleep questionnaires and autonomic arousals using pulse wave amplitude.
Correlations with sleep questionnaires
Correlation between sleep questionnaires and pulse transit time analysis.
Correlations with sleep questionnaires
Correlation between sleep questionnaires and mandibular movement analysis by non-invasive magnetic distance sensors.
Correlations with sleep questionnaires
Correlation between sleep questionnaires and cerebral oxygenation analysis.
Correlations with sleep questionnaires
Correlation between sleep questionnaires and the type of CAP.
Correlations with psychological and neuropsychological tests
Correlation between psychological and neuropsychological scores and the different calculated AHI.
Correlations with psychological and neuropsychological tests
Correlation between psychological and neuropsychological scores and the types of CAP.
Correlations with psychological and neuropsychological tests
Correlation between psychological and mean nocturnal cerebral oxygenation.
Alternative analysis
Correlation between the AHI obtained from P(S)G and the AHI obtained using respiratory inductance plethysmography.
Alternative analysis in (pre-)teens
Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband.
Alternative analysis
Correlations between the sleep stages and AHI obtained from manual analysis of PSG and an automatic analysis.
Effect of treatment on Griffiths-III score
Comparison of neurodevelopment evaluation using the Griffiths-III between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score <70.
Effect of treatment on WPPSI-IV score
Comparison of neurodevelopment evaluation using the WPPSI-IV between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score <70.
Effect of treatment on WISC-V score
Comparison of neurodevelopment evaluation using the WISC-V between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score <70.
Effect of treatment
Comparison of the percentage of types of CAP between baseline and 1 year following treatment.
Effect of treatment
Comparison of mean cerebral oxygenation between baseline and 1 year following treatment.
Effect of treatment on Pittsburgh Sleep Quality Index (PSQI)
Comparison of PSQI scores between baseline and 1 year following treatment. PSQI max score = 21. Threshold values for the PSQI scale: 0-4: Good, 5-8: Moderate, >9: Bad sleep quality.
Effect of treatment on Epworth sleepiness scale (ESS)
Comparison of ESS scores between baseline and 1 year following treatment. ESS max score = 33. Threshold values for the ESS scale: <8: No, 9-14: Moderate, >15: Severe sleepiness.

Full Information

First Posted
April 29, 2021
Last Updated
February 3, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04971850
Brief Title
Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Acronym
TRSPed
Official Title
Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB. The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.
Detailed Description
One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB. In addition, the clinical impact of SDB and the benefit of treatment are still not clear in children and young adults, including neurocognitive and developmental perspective. Finally, the validation of simplified tools could optimize and simplify the detection of SDB in children and young adults. Patients scheduled to perform a diagnostic PSG for routine clinical care will have additional recordings and questionnaires as part of the study. The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-disordered Breathing (SDB)
Keywords
Sleep-disordered breathing (SDB), Poly(somno)graphy (P(S)G), Cerebral oxygenation, Cyclic alternating pattern (CAP), Psychological and neuropsychological tests, Screening questionnaires, Treatment of SDB

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep-disordered breathing (SDB)
Arm Type
Experimental
Arm Description
Patients aged 1 to 20 years old with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study for their clinical care.
Intervention Type
Other
Intervention Name(s)
Sleep study
Intervention Description
Procedures added by research during PSG : SDB screening questionnaires Electromyography (EMG) of accessory and abdominal muscles Cerebral oxygenation Mandibular movements Sleep headband (pre-teens and teens) or other connected device Automatic PSG analyzes Psychological and neuropsychological assessment The recordings of the study will be repeated at one year if the patient needs a treatment (surgery or noninvasive ventilation) following the results of the PSG.
Primary Outcome Measure Information:
Title
Anxiety
Description
Anxiety questionnaire using the Revised Children's Manifest Anxiety Scale (RCMAS), with an anxiety being defined by a total T-score ≥60. Mean normal value of T-score is 50 ± 10.
Time Frame
The day after the P(S)G
Title
Depression
Description
Depression questionnaire using the Multiscore Depression Inventory for Children (MDI-C), with an abnormal score being defined by a T-score ≥70. Mean normal value of T-score is 50 ± 10.
Time Frame
The day after the P(S)G
Title
Quality of life
Description
Quality of life questionnaire using the Pediatric Quality of Life Inventory (PedsQL). The higher the score, the better the quality of life. Min value = 0. Max value = 100.
Time Frame
The day after the P(S)G
Title
Sensoriality
Description
Sensoriality using the Sensory profile test. Atypical performance for a raw score <122. Min value = 38. Max value = 190.
Time Frame
The day after the P(S)G
Title
NEPSY-II memory evaluation
Description
Memory evaluation using the NEPSY-II test. Mean normal score is 10 ± 3. Abnormal for a score <4.
Time Frame
The day after the P(S)G
Title
Children Memory Scale
Description
Memory evaluation using the Children Memory Scale test. Mean normal score is 10 ± 3. Abnormal for a score <4.
Time Frame
The day after the P(S)G
Title
Attention
Description
Attention evaluation using the TAP test. Abnormal for a T-score <30. Mean normal value of T-score is 50 ± 10.
Time Frame
The day after the P(S)G
Title
NEPSY-II score
Description
Executive function evaluation using the NEPSY-II. Mean normal score tests is 10 ± 3, abnormal for a score <4.
Time Frame
The day after the P(S)G
Title
Trail Making test score
Description
Executive function evaluation using the Trail Making test. Mean normal score is 10 ± 3, abnormal for a score <4.
Time Frame
The day after the P(S)G
Title
KiTAP subtests score
Description
Executive function evaluation using the KiTAP subtests. Abnormal T-score <30, with mean normal value of T-score is 50 ± 10.
Time Frame
The day after the P(S)G
Title
Behavior
Description
Behavior evaluation using the Child Behaviour Checklist (CBCL). Abnormal T-score >65. Mean normal value of T-score is 50 ± 10.
Time Frame
The day after the P(S)G
Title
Griffiths-III score
Description
Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score <70.
Time Frame
The day after the P(S)G
Title
WPPSI-IV score
Description
Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score <70.
Time Frame
The day after the P(S)G
Title
WISC-V score
Description
Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score <70.
Time Frame
The day after the P(S)G
Title
Language
Description
Language evaluation using the Griffiths-III test. Mean normal score is 100 ± 15. Abnormal for a score <70.
Time Frame
The day after the P(S)G
Secondary Outcome Measure Information:
Title
Sleep disturbance
Description
Score of the sleep disturbance scale for children (SDSC) to detect the presence and severity of SDB Children < 4 years old: Min value 3, max value 15. Abnormal if score >4. Children > 4 years old: Min value 5, max value 25. Abnormal if score >12.
Time Frame
The day after baseline P(S)G
Title
3D facial surface analysis
Description
Geometric morphometric approach based on 3D facial surface analysis of linear distances between 25 pairs of craniofacial landmarks, defined as direct Euclidean distance (in mm) between the two points.
Time Frame
The day after baseline P(S)G
Title
3D facial surface analysis
Description
Geometric morphometric approach based on 3D facial surface analysis of geodesic distances between 25 pairs of craniofacial landmarks, defined as the shortest distance (in mm) between two points when following the contour of the face/skin.
Time Frame
The day after baseline P(S)G
Title
3D facial surface analysis
Description
Geometric morphometric approach based on 3D facial surface analysis of angular measurements between 25 pairs of craniofacial landmarks, defined as the angles (in degree) between sets of three landmarks.
Time Frame
The day after baseline P(S)G
Title
Changing detection of respiratory events
Description
Comparison between the apnea-hypopnea index (AHI) obtained from the P(S)G and the AHI calculated using respiratory muscle EMG
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Changing detection of respiratory events
Description
Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account hypoventilation and flow limitation
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Changing detection of respiratory events
Description
Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account autonomic arousals using the pulse wave amplitude
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Changing detection of respiratory events
Description
Comparison between the AHI obtained from the P(S)G and the AHI calculated using the pulse transit time
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Changing detection of respiratory events
Description
Comparison between the AHI obtained from the P(S)G and the AHI calculated using mandibular movements
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Changing detection of respiratory events
Description
Comparison between the AHI obtained from the P(S)G and the AHI calculated using cerebral oxygenation desaturations
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with clinical signs of SDB
Description
Correlation between clinical signs by questionnaire and respiratory muscles power by EMG.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with clinical signs of SDB
Description
Correlation between clinical signs by questionnaire and hypoventilation and flow limitation scores by P(S)G.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with clinical signs of SDB
Description
Correlation between clinical signs by questionnaire and autonomic arousals using pulse wave amplitude by pulse oximetry.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with clinical signs of SDB
Description
Correlation between clinical signs by questionnaire and pulse transit time analysis by ECG.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with clinical signs of SDB
Description
Correlation between clinical signs by questionnaire and mandibular movement analysis by non-invasive magnetic distance sensors.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with clinical signs of SDB
Description
Correlation between clinical signs by questionnaire and cerebral oxygenation analysis by near-infrared spectroscopy.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with clinical signs of SDB
Description
Correlation between clinical signs by questionnaire and the type of CAP by EEG.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with pulse oximetry
Description
Correlation between pulse oximetry and respiratory muscles power by EMG.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with pulse oximetry
Description
Correlation between pulse oximetry and hypoventilation and flow limitation scores by P(S)G.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with pulse oximetry
Description
Correlation between pulse oximetry and autonomic arousals using pulse wave amplitude.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with pulse oximetry
Description
Correlation between pulse oximetry and pulse transit time analysis.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with pulse oximetry
Description
Correlation between pulse oximetry and mandibular movement analysis by non-invasive magnetic distance sensors.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with pulse oximetry
Description
Correlation between pulse oximetry and cerebral oxygenation analysis by near-infrared spectroscopy.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with pulse oximetry
Description
Correlation between pulse oximetry and the type of CAP.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with sleep questionnaires
Description
Correlation between sleep questionnaires and respiratory muscles EMG.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with sleep questionnaires
Description
Correlation between sleep questionnaires and hypoventilation and flow limitation scores by P(S)G.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with sleep questionnaires
Description
Correlation between sleep questionnaires and autonomic arousals using pulse wave amplitude.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with sleep questionnaires
Description
Correlation between sleep questionnaires and pulse transit time analysis.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with sleep questionnaires
Description
Correlation between sleep questionnaires and mandibular movement analysis by non-invasive magnetic distance sensors.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with sleep questionnaires
Description
Correlation between sleep questionnaires and cerebral oxygenation analysis.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with sleep questionnaires
Description
Correlation between sleep questionnaires and the type of CAP.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with psychological and neuropsychological tests
Description
Correlation between psychological and neuropsychological scores and the different calculated AHI.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with psychological and neuropsychological tests
Description
Correlation between psychological and neuropsychological scores and the types of CAP.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Correlations with psychological and neuropsychological tests
Description
Correlation between psychological and mean nocturnal cerebral oxygenation.
Time Frame
The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Title
Alternative analysis
Description
Correlation between the AHI obtained from P(S)G and the AHI obtained using respiratory inductance plethysmography.
Time Frame
The day after baseline P(S)G
Title
Alternative analysis in (pre-)teens
Description
Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband.
Time Frame
The day after baseline P(S)G
Title
Alternative analysis
Description
Correlations between the sleep stages and AHI obtained from manual analysis of PSG and an automatic analysis.
Time Frame
The day after baseline P(S)G
Title
Effect of treatment on Griffiths-III score
Description
Comparison of neurodevelopment evaluation using the Griffiths-III between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score <70.
Time Frame
At one year
Title
Effect of treatment on WPPSI-IV score
Description
Comparison of neurodevelopment evaluation using the WPPSI-IV between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score <70.
Time Frame
At one year
Title
Effect of treatment on WISC-V score
Description
Comparison of neurodevelopment evaluation using the WISC-V between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score <70.
Time Frame
At one year
Title
Effect of treatment
Description
Comparison of the percentage of types of CAP between baseline and 1 year following treatment.
Time Frame
At one year
Title
Effect of treatment
Description
Comparison of mean cerebral oxygenation between baseline and 1 year following treatment.
Time Frame
At one year
Title
Effect of treatment on Pittsburgh Sleep Quality Index (PSQI)
Description
Comparison of PSQI scores between baseline and 1 year following treatment. PSQI max score = 21. Threshold values for the PSQI scale: 0-4: Good, 5-8: Moderate, >9: Bad sleep quality.
Time Frame
At one year
Title
Effect of treatment on Epworth sleepiness scale (ESS)
Description
Comparison of ESS scores between baseline and 1 year following treatment. ESS max score = 33. Threshold values for the ESS scale: <8: No, 9-14: Moderate, >15: Severe sleepiness.
Time Frame
At one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 1 to 20 years with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study Written informed consent Exclusion Criteria: No social insurance Significant psychomotor retardation Cooperation not possible Significant agitation Acute condition and/or temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection) Patient under guardianship/curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte Fauroux, MD, PhD
Phone
1 71 19 60 92
Ext
+33
Email
brigitte.fauroux@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Morel
Phone
1 71 19 63 46
Ext
+33
Email
helene.morel@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Fauroux, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sonia Khirani, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte Fauroux, MD, PhD
Phone
1 71 19 60 92
Ext
+33
Email
brigitte.fauroux@aphp.fr
First Name & Middle Initial & Last Name & Degree
Lucie Griffon, MD
First Name & Middle Initial & Last Name & Degree
Mathilde Cozzo, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults

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