NCT04971850

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Feb 2022Feb 2028

First Submitted

Initial submission to the registry

April 29, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

February 2, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

April 29, 2021

Last Update Submit

September 8, 2025

Conditions

Sleep-disordered Breathing (SDB)

Keywords

Sleep-disordered breathing (SDB)Poly(somno)graphy (P(S)G)Cerebral oxygenationCyclic alternating pattern (CAP)Psychological and neuropsychological testsScreening questionnairesTreatment of SDB

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (44)

  • Sleep disturbance

    The day after baseline P(S)G

  • 3D facial surface analysis

    The day after baseline P(S)G

  • 3D facial surface analysis

    The day after baseline P(S)G

  • 3D facial surface analysis

    The day after baseline P(S)G

  • Changing detection of respiratory events

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

  • +39 more secondary outcomes

Study Arms (1)

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.

Other: Sleep study

Interventions

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.

Sleep-disordered breathing (SDB)

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Brigitte Fauroux, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Sonia Khirani, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Brigitte Fauroux, MD, PhD

CONTACT

1 71 19 60 92brigitte.fauroux@aphp.fr

Hélène Morel

CONTACT

1 71 19 63 46helene.morel@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

July 22, 2021

Study Start

February 2, 2022

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)