Sleep-disordered Breathing (SDB)TRSPedNCT04971850
Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
A study testing Sleep study in people with Sleep-disordered Breathing (SDB), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Sleep-disordered Breathing (SDB)
- What is being tested?
- Sleep study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2022to Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Brigitte Fauroux, MD, PhD, 1 71 19 60 92 ext. +33, brigitte.fauroux@aphp.fr
Lucie Griffon, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep-disordered Breathing (SDB)
- Being tested
- Sleep study
- 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
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep-disordered breathing (SDB) | Experimental | 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. Receives: Other: Sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The day after the P(S)G
Secondary outcomes (44)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At one year
Effect of treatment
Comparison of the percentage of types of CAP between baseline and 1 year following treatment.
Measured: At one year
Effect of treatment
Comparison of mean cerebral oxygenation between baseline and 1 year following treatment.
Measured: 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.
Measured: 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.
Measured: At one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start2 Feb 2022
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered Breathing (SDB)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Brigitte Fauroux, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisSonia Khirani, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971850
- Sponsor's protocol ID
- APHP210042
- Other IDs
- 2020-A03083-36
- Acronym
- TRSPed
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2021
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No