BodySleep Algorithm for OSA Diagnosis in Children

NCT ID: NCT07345312

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-10

Study Completion Date

2026-01-15

Brief Summary

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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.

Detailed Description

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The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSA) requires the performance of polysomnography (PSG) in the hospital with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. During the night. The PSG gives the index of obstructive apnea-hypopnea (IAHO) necessary for the diagnosis of OSAS and to determine its severity. But the PSG is a rather cumbersome examination, sometimes challenging to perform in children, with several sensors and electrodes to install (electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), necessary to determine the periods of wakefulness -sleep and intra-sleep micro-arousals, nasal cannula, thoracoabdominal straps, pulse oximetry, actimetry to score respiratory events), 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 service (A1-Nox, ResMed) combines actigraphy data (body position during sleep) and induction plethysmography signal resulting from the thoracoabdominal belts to identify sleep-wake stages could be used instead of EEG, EOG and EMG electrodes. The BodySleep algorithm associated only with respiratory signals (nasal cannula, thoracoabdominal straps, pulse oximetry, actimetry) could be used to identify respiratory events. Thus the child would have fewer sensors installed on him.

The hypothesis of this study is that the BodySleep algorithm associated with respiratory signals can identify OSA in children.

Conditions

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Obstructive Sleep Apnea of Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Polysomnography

PSG performed prospectively in routine care in children suspected of OSA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Age under 2 years and over 18 years
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Nancy

Nancy, Grand Est, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Iulia-Cristina IOAN, MD PhD

Role: CONTACT

+33 3 83 15 47 94

Facility Contacts

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Iulia Ioan, MDPhD

Role: primary

0383154794

References

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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.

Reference Type BACKGROUND
PMID: 33594617 (View on PubMed)

Other Identifiers

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2023PI030

Identifier Type: -

Identifier Source: org_study_id

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