BodySleep algorithm for diagnosing obstructive sleep apnea in children
The Use of the BodySleep Algorithm (ResMed) for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children
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 |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy, Grand Est) |
| Trial ID | NCT07345312 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Automated respiratory-based scoring methods have shown promising accuracy in adults, but pediatric validation is limited, so this application in children remains relatively novel.
Eligibility criteria
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 this trial is running
Nancy, Grand Est
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.