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NCT Number: NCT07345312

BodySleep Algorithm for OSA Diagnosis in Children

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nancy

Nancy, Grand Est, 54000, France

Location status: Recruiting

Location contact

Iulia Ioan, MDPhD

CONTACT

[email protected]

0383154794

Iulia Ioan, MDPhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Polysomnography

Diagnostic Test

PSG performed prospectively in routine care in children suspected of OSA

Primary outcomes

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

    Time frame: One night

    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

Study contacts

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

Iulia-Cristina IOAN, MD PhD

CONTACT

[email protected]

+33 3 83 15 47 94

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

The Use of the BodySleep Algorithm (ResMed) for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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