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NCT Number: NCT04971850

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.

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Key information

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location status: Recruiting

Location contact

Brigitte Fauroux, MD, PhD

CONTACT

[email protected]

1 71 19 60 92 ext. +33

Lucie Griffon, MD

SUB_INVESTIGATOR

Mathilde Cozzo, MSc

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Study

Other

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 outcomes

  1. Anxiety

    Time frame: The day after the P(S)G

    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.

  2. Depression

    Time frame: The day after the P(S)G

    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.

  3. Quality of life

    Time frame: The day after the P(S)G

    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.

  4. Sensoriality

    Time frame: The day after the P(S)G

    Sensoriality using the Sensory profile test. Atypical performance for a raw score <122. Min value = 38. Max value = 190.

  5. NEPSY-II memory evaluation

    Time frame: The day after the P(S)G

    Memory evaluation using the NEPSY-II test. Mean normal score is 10 ± 3. Abnormal for a score <4.

  6. Children Memory Scale

    Time frame: The day after the P(S)G

    Memory evaluation using the Children Memory Scale test. Mean normal score is 10 ± 3. Abnormal for a score <4.

  7. Attention

    Time frame: The day after the P(S)G

    Attention evaluation using the TAP test. Abnormal for a T-score <30. Mean normal value of T-score is 50 ± 10.

  8. NEPSY-II score

    Time frame: The day after the P(S)G

    Executive function evaluation using the NEPSY-II. Mean normal score tests is 10 ± 3, abnormal for a score <4.

  9. Trail Making test score

    Time frame: The day after the P(S)G

    Executive function evaluation using the Trail Making test. Mean normal score is 10 ± 3, abnormal for a score <4.

  10. KiTAP subtests score

    Time frame: The day after the P(S)G

    Executive function evaluation using the KiTAP subtests. Abnormal T-score <30, with mean normal value of T-score is 50 ± 10.

  11. Behavior

    Time frame: The day after the P(S)G

    Behavior evaluation using the Child Behaviour Checklist (CBCL). Abnormal T-score >65. Mean normal value of T-score is 50 ± 10.

  12. Griffiths-III score

    Time frame: The day after the P(S)G

    Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score <70.

  13. WPPSI-IV score

    Time frame: The day after the P(S)G

    Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score <70.

  14. WISC-V score

    Time frame: The day after the P(S)G

    Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score <70.

  15. Language

    Time frame: The day after the P(S)G

    Language evaluation using the Griffiths-III test. Mean normal score is 100 ± 15. Abnormal for a score <70.

Secondary outcomes

  1. Sleep disturbance

    Time frame: The day after baseline P(S)G

    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.

  2. 3D facial surface analysis

    Time frame: The day after baseline P(S)G

    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.

  3. 3D facial surface analysis

    Time frame: The day after baseline P(S)G

    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.

  4. 3D facial surface analysis

    Time frame: The day after baseline P(S)G

    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.

  5. Changing detection of respiratory events

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Comparison between the apnea-hypopnea index (AHI) obtained from the P(S)G and the AHI calculated using respiratory muscle EMG

  6. Changing detection of respiratory events

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account hypoventilation and flow limitation

  7. Changing detection of respiratory events

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account autonomic arousals using the pulse wave amplitude

  8. Changing detection of respiratory events

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Comparison between the AHI obtained from the P(S)G and the AHI calculated using the pulse transit time

  9. Changing detection of respiratory events

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Comparison between the AHI obtained from the P(S)G and the AHI calculated using mandibular movements

  10. Changing detection of respiratory events

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Comparison between the AHI obtained from the P(S)G and the AHI calculated using cerebral oxygenation desaturations

  11. Correlations with clinical signs of SDB

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between clinical signs by questionnaire and respiratory muscles power by EMG.

  12. Correlations with clinical signs of SDB

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between clinical signs by questionnaire and hypoventilation and flow limitation scores by P(S)G.

  13. Correlations with clinical signs of SDB

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between clinical signs by questionnaire and autonomic arousals using pulse wave amplitude by pulse oximetry.

  14. Correlations with clinical signs of SDB

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between clinical signs by questionnaire and pulse transit time analysis by ECG.

  15. Correlations with clinical signs of SDB

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between clinical signs by questionnaire and mandibular movement analysis by non-invasive magnetic distance sensors.

  16. Correlations with clinical signs of SDB

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between clinical signs by questionnaire and cerebral oxygenation analysis by near-infrared spectroscopy.

  17. Correlations with clinical signs of SDB

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between clinical signs by questionnaire and the type of CAP by EEG.

  18. Correlations with pulse oximetry

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between pulse oximetry and respiratory muscles power by EMG.

  19. Correlations with pulse oximetry

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between pulse oximetry and hypoventilation and flow limitation scores by P(S)G.

  20. Correlations with pulse oximetry

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between pulse oximetry and autonomic arousals using pulse wave amplitude.

  21. Correlations with pulse oximetry

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between pulse oximetry and pulse transit time analysis.

  22. Correlations with pulse oximetry

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between pulse oximetry and mandibular movement analysis by non-invasive magnetic distance sensors.

  23. Correlations with pulse oximetry

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between pulse oximetry and cerebral oxygenation analysis by near-infrared spectroscopy.

  24. Correlations with pulse oximetry

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between pulse oximetry and the type of CAP.

  25. Correlations with sleep questionnaires

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between sleep questionnaires and respiratory muscles EMG.

  26. Correlations with sleep questionnaires

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between sleep questionnaires and hypoventilation and flow limitation scores by P(S)G.

  27. Correlations with sleep questionnaires

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between sleep questionnaires and autonomic arousals using pulse wave amplitude.

  28. Correlations with sleep questionnaires

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between sleep questionnaires and pulse transit time analysis.

  29. Correlations with sleep questionnaires

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between sleep questionnaires and mandibular movement analysis by non-invasive magnetic distance sensors.

  30. Correlations with sleep questionnaires

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between sleep questionnaires and cerebral oxygenation analysis.

  31. Correlations with sleep questionnaires

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between sleep questionnaires and the type of CAP.

  32. Correlations with psychological and neuropsychological tests

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between psychological and neuropsychological scores and the different calculated AHI.

  33. Correlations with psychological and neuropsychological tests

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between psychological and neuropsychological scores and the types of CAP.

  34. Correlations with psychological and neuropsychological tests

    Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery

    Correlation between psychological and mean nocturnal cerebral oxygenation.

  35. Alternative analysis

    Time frame: The day after baseline P(S)G

    Correlation between the AHI obtained from P(S)G and the AHI obtained using respiratory inductance plethysmography.

  36. Alternative analysis in (pre-)teens

    Time frame: The day after baseline P(S)G

    Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband.

  37. Alternative analysis

    Time frame: The day after baseline P(S)G

    Correlations between the sleep stages and AHI obtained from manual analysis of PSG and an automatic analysis.

  38. Effect of treatment on Griffiths-III score

    Time frame: At one year

    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.

  39. Effect of treatment on WPPSI-IV score

    Time frame: At one year

    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.

  40. Effect of treatment on WISC-V score

    Time frame: At one year

    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.

  41. Effect of treatment

    Time frame: At one year

    Comparison of the percentage of types of CAP between baseline and 1 year following treatment.

  42. Effect of treatment

    Time frame: At one year

    Comparison of mean cerebral oxygenation between baseline and 1 year following treatment.

  43. Effect of treatment on Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At one year

    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.

  44. Effect of treatment on Epworth sleepiness scale (ESS)

    Time frame: At one year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brigitte Fauroux, MD, PhD

CONTACT

[email protected]

1 71 19 60 92 ext. +33

Hélène Morel

CONTACT

[email protected]

1 71 19 63 46 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: TRSPed

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2021
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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