BodySleep Algorithm for OSA Diagnosis in Children

NCT07345312 | Recruiting

• 1 other identifier: 2023PI030
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosing obstructive sleep apnea-hypopnea syndrome in children (OSA) requires the performance of polysomnography (PSG) in the hospital which is sometimes challenging to perform in children, and time-consuming for installation and analysis. Simplified recording and analysis methods are preferable in children but require validation in this population. The BodySleep automatic algorithm of the polysomnograph used in our lab (A1-Nox, ResMed) associated only with respiratory signals could be used to identify respiratory events. Thus the child would have fewer sensors installed on him.

Conditions

Obstructive Sleep Apnea of Child

Outcome Measures

Primary Outcomes (1)

• Obstructive apnea-hypopnea index by BodySleep in comparison with OAHI by PSG

  To determine if the obstructive apnea-hypopnea index (OAHI) obtained by the BodySleep algorithm is underestimated in comparison with the OAHI obtained by the PSG

  One night

Interventions

Polysomnography DIAGNOSTIC_TEST

PSG performed prospectively in routine care in children suspected of OSA

Eligibility Criteria

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

Study Population

A retrospective study including children aged 2 to 18 years addressed for a PSG.

You may qualify if:

• Children suspected of OSA who are addressed for a PSG by the ear nose throat physician, pediatric pulmonologist, neurologist, psychiatrist, sleep specialist, genetics, and nutritionist physician.
• Age between 2 and 18 years

You may not qualify if:

• Age under 2 years and over 18 years

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, Grand Est, 54000, France

RECRUITING

Related Publications (1)

• Dietz-Terjung S, Martin AR, Finnsson E, Agustsson JS, Helgason S, Helgadottir H, Welsner M, Taube C, Weinreich G, Schobel C. Proof of principle study: diagnostic accuracy of a novel algorithm for the estimation of sleep stages and disease severity in patients with sleep-disordered breathing based on actigraphy and respiratory inductance plethysmography. Sleep Breath. 2021 Dec;25(4):1945-1952. doi: 10.1007/s11325-021-02316-0. Epub 2021 Feb 16.

  PMID: 33594617 BACKGROUND

MeSH Terms

Interventions

Polysomnography

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Iulia-Cristina IOAN, MD PhD

CONTACT

+33 3 83 15 47 94; 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: March 6, 2023
• First Posted: January 15, 2026
• Study Start: January 10, 2026
• Primary Completion: January 10, 2026
• Study Completion: January 15, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)