Video-respiratory Polygraphy in Children

NCT06287333 | Not Yet Recruiting

• 1 other identifier: 2023PI221
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not.

Conditions

Sleep Apnea, Obstructive

Keywords

child; polysomnography; polygraphy

Outcome Measures

Primary Outcomes (1)

• OAHI in video-RP significantly correlated with OAHI in PSG

  Value of the OAHI obtained by the video-RP for each of the children in the groups with OSAS (who have an OAHI ≥ 1/h in PSG) and without OSAS (who have an OAHI \< 1/h in PSG) will be correlated with the value of OAHI obtained by PSG using a Fisher exact test

  One night

Secondary Outcomes (2)

• Diagnostic ability of video-RP to identify OSAS in children

  One night

• Diagnostic ability of video-RP to identify moderate-severe OSAS in children

  One night

Interventions

Polysomnography in routine care DIAGNOSTIC_TEST

Children performed a polysomnography in routine clinical care

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 2 to 19 years adressed for a PSG in routine clinical care for suspicion of OSAS by the ear-nose-throat physician, pediatric pulmonologist, sleep specialist, endocrinologist, genetician.

You may qualify if:

• Children with suspicion of OSAS
• Interpretable polysomnography

You may not qualify if:

• Non-interpretable polysomnography

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (2)

• Horne AF, Olafsdottir KA, Arnardottir ES. In-person vs video hookup instructions: a comparison of home sleep apnea testing quality. J Clin Sleep Med. 2022 Aug 1;18(8):2069-2074. doi: 10.5664/jcsm.10084.

  PMID: 35510598 RESULT

• Sivan Y, Kornecki A, Schonfeld T. Screening obstructive sleep apnoea syndrome by home videotape recording in children. Eur Respir J. 1996 Oct;9(10):2127-31. doi: 10.1183/09031936.96.09102127.

  PMID: 8902478 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Iulia IOAN, MD PhD

CONTACT

+33383154794; ic.ioan@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: February 22, 2024
• Primary Completion: February 22, 2024
• Study Completion: February 28, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share