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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep-disordered Breathing (SDB)
• Intervention / Treatment: Other: Sleep study

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène Morel; Phone Number: +33 1 71 19 63 46; Email: helene.morel@aphp.fr
• Study Contact Backup: Name: Brigitte Fauroux, MD, PhD; Phone Number: +33 1 71 19 60 92; Email: brigitte.fauroux@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker-Enfants Malades
    • Sub-Investigator: Mathilde Cozzo, MSc
    • Contact: Brigitte Fauroux, MD, PhD; Phone Number: +33 1 71 19 60 92; Email: brigitte.fauroux@aphp.fr
    • Sub-Investigator: Lucie Griffon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sleep-disordered breathing (SDB); 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.

Other: Sleep study; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The day after the P(S)G
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.	The day after the P(S)G
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.	The day after the P(S)G
Sensoriality	Sensoriality using the Sensory profile test. Atypical performance for a raw score <122. Min value = 38. Max value = 190.	The day after the P(S)G
NEPSY-II memory evaluation	Memory evaluation using the NEPSY-II test. Mean normal score is 10 ± 3. Abnormal for a score <4.	The day after the P(S)G
Children Memory Scale	Memory evaluation using the Children Memory Scale test. Mean normal score is 10 ± 3. Abnormal for a score <4.	The day after the P(S)G
Attention	Attention evaluation using the TAP test. Abnormal for a T-score <30. Mean normal value of T-score is 50 ± 10.	The day after the P(S)G
NEPSY-II score	Executive function evaluation using the NEPSY-II. Mean normal score tests is 10 ± 3, abnormal for a score <4.	The day after the P(S)G
Trail Making test score	Executive function evaluation using the Trail Making test. Mean normal score is 10 ± 3, abnormal for a score <4.	The day after the P(S)G
KiTAP subtests score	Executive function evaluation using the KiTAP subtests. Abnormal T-score <30, with mean normal value of T-score is 50 ± 10.	The day after the P(S)G
Behavior	Behavior evaluation using the Child Behaviour Checklist (CBCL). Abnormal T-score >65. Mean normal value of T-score is 50 ± 10.	The day after the P(S)G
Griffiths-III score	Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score <70.	The day after the P(S)G
WPPSI-IV score	Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score <70.	The day after the P(S)G
WISC-V score	Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score <70.	The day after the P(S)G
Language	Language evaluation using the Griffiths-III test. Mean normal score is 100 ± 15. Abnormal for a score <70.	The day after the P(S)G

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The day after baseline P(S)G
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.	The day after baseline P(S)G
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.	The day after baseline P(S)G
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.	The day after baseline P(S)G
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	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
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	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
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	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events	Comparison between the AHI obtained from the P(S)G and the AHI calculated using the pulse transit time	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events	Comparison between the AHI obtained from the P(S)G and the AHI calculated using mandibular movements	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events	Comparison between the AHI obtained from the P(S)G and the AHI calculated using cerebral oxygenation desaturations	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB	Correlation between clinical signs by questionnaire and respiratory muscles power by EMG.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB	Correlation between clinical signs by questionnaire and hypoventilation and flow limitation scores by P(S)G.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB	Correlation between clinical signs by questionnaire and autonomic arousals using pulse wave amplitude by pulse oximetry.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB	Correlation between clinical signs by questionnaire and pulse transit time analysis by ECG.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB	Correlation between clinical signs by questionnaire and mandibular movement analysis by non-invasive magnetic distance sensors.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB	Correlation between clinical signs by questionnaire and cerebral oxygenation analysis by near-infrared spectroscopy.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB	Correlation between clinical signs by questionnaire and the type of CAP by EEG.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry	Correlation between pulse oximetry and respiratory muscles power by EMG.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry	Correlation between pulse oximetry and hypoventilation and flow limitation scores by P(S)G.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry	Correlation between pulse oximetry and autonomic arousals using pulse wave amplitude.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry	Correlation between pulse oximetry and pulse transit time analysis.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry	Correlation between pulse oximetry and mandibular movement analysis by non-invasive magnetic distance sensors.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry	Correlation between pulse oximetry and cerebral oxygenation analysis by near-infrared spectroscopy.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry	Correlation between pulse oximetry and the type of CAP.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires	Correlation between sleep questionnaires and respiratory muscles EMG.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires	Correlation between sleep questionnaires and hypoventilation and flow limitation scores by P(S)G.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires	Correlation between sleep questionnaires and autonomic arousals using pulse wave amplitude.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires	Correlation between sleep questionnaires and pulse transit time analysis.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires	Correlation between sleep questionnaires and mandibular movement analysis by non-invasive magnetic distance sensors.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires	Correlation between sleep questionnaires and cerebral oxygenation analysis.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires	Correlation between sleep questionnaires and the type of CAP.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with psychological and neuropsychological tests	Correlation between psychological and neuropsychological scores and the different calculated AHI.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with psychological and neuropsychological tests	Correlation between psychological and neuropsychological scores and the types of CAP.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with psychological and neuropsychological tests	Correlation between psychological and mean nocturnal cerebral oxygenation.	The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Alternative analysis	Correlation between the AHI obtained from P(S)G and the AHI obtained using respiratory inductance plethysmography.	The day after baseline P(S)G
Alternative analysis in (pre-)teens	Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband.	The day after baseline P(S)G
Alternative analysis	Correlations between the sleep stages and AHI obtained from manual analysis of PSG and an automatic analysis.	The day after baseline P(S)G
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.	At one year
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.	At one year
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.	At one year
Effect of treatment	Comparison of the percentage of types of CAP between baseline and 1 year following treatment.	At one year
Effect of treatment	Comparison of mean cerebral oxygenation between baseline and 1 year following treatment.	At one year
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.	At one year
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.	At one year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Brigitte Fauroux, MD, PhD, Assistance Publique - Hopitaux de Paris; Study Director: Sonia Khirani, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cerebral oxygenation; Sleep-disordered breathing (SDB); Poly(somno)graphy (P(S)G); Cyclic alternating pattern (CAP); Psychological and neuropsychological tests; Screening questionnaires; Treatment of SDB
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes
• Other Study ID Numbers: APHP210042; 2020-A03083-36 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No