BodySleep algorithm for diagnosing obstructive sleep apnea in children
Official title: The Use of the BodySleep Algorithm (ResMed) for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children
Run by Central Hospital, Nancy, France · NCT07345312 · Data updated 2026-11-12
This project will test whether the BodySleep automatic algorithm using only respiratory signals and actigraphy can accurately detect obstructive sleep apnea in children aged 2–18.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy, Grand Est) |
| Status | Recruiting |
| Started | January 10, 2026 |
| Main results expected | January 10, 2026 |
| Study ends | January 15, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT07345312 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2 to 18 who are referred for an in-hospital polysomnography because a clinician suspects obstructive sleep apnea.
✕Probably not a fit
Children under 2 years old (excluded from the protocol) and patients who require EEG-based assessment for seizures, complex parasomnias, or detailed sleep architecture evaluation are unlikely to benefit from the simplified sensor approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study applies the BodySleep automated algorithm to overnight polysomnography recordings that use fewer sensors (nasal cannula, thoracoabdominal belts, pulse oximetry, and actimetry) and compares its respiratory-event detection to standard full PSG scoring. Children referred for suspected OSA aged 2 to 18 will undergo in-hospital overnight PSG at CHRU de Nancy with simultaneous BodySleep output. The approach seeks to replace EEG/EOG/EMG-derived sleep staging with algorithm-derived sleep-wake estimates from plethysmography and actigraphy to identify respiratory events. The study is single-center and aims to validate whether a simplified sensor set provides clinically reliable indices for pediatric OSA diagnosis.
Why it matters
Potential benefit: If successful, children could have overnight sleep testing with fewer sensors, making the test more comfortable and easier to perform while still identifying sleep apnea.
How similar studies have gone: Automated respiratory-based scoring methods have shown promising accuracy in adults, but pediatric validation is limited, so this application in children remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHRU de Nancy
Nancy, Grand Est, France Recruiting
Study contacts
- Study coordinator: Iulia-Cristina IOAN, MD PhD
- Email: ic.ioan@chru-nancy.fr
- Phone: +33 3 83 15 47 94
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.