Actively Recruiting

Age: 2Years - 18Years
All Genders
ID07345312

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

Led by Central Hospital, Nancy, France · Updated on 2026-01-15

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a simplified method to diagnose obstructive sleep apnea-hypopnea syndrome (OSA) in children. The current standard for diagnosis is polysomnography (PSG), which is performed in a hospital setting with many sensors and electrodes, making it challenging and time-consuming, especially for children. This study aims to validate the BodySleep automatic algorithm, which uses fewer sensors and focuses on respiratory signals to detect respiratory events related to OSA in children. The study uses the BodySleep algorithm applied to data from respiratory signals such as nasal cannula, thoracoabdominal straps, pulse oximetry, and actimetry. This method would reduce the number of sensors needed compared to standard PSG, which requires additional electrodes for brain and muscle activity monitoring. The PSG test is performed prospectively as part of routine care for children suspected of having OSA, and the BodySleep algorithm's performance is compared to the standard PSG results. Participants will undergo one night of PSG monitoring with video and nurse supervision to ensure sensor placement. Researchers compare the obstructive apnea-hypopnea index (OAHI) measured by the BodySleep algorithm with the OAHI from the full PSG to assess accuracy. The study involves children aged 2 to 18 suspected of OSA. The total participation includes the diagnostic PSG night, with data analysis to validate the new algorithm for potential simpler diagnosis in pediatric patients.

CONDITIONS

Brief Title

BodySleep Algorithm for OSA Diagnosis in Children

Who Can Participate

Age: 2Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children suspected of obstructive sleep apnea who are referred for a polysomnography by specialists such as ear, nose, and throat physicians, pediatric pulmonologists, neurologists, psychiatrists, sleep specialists, geneticists, or nutritionists
  • Age between 2 and 18 years
Not Eligible

You will not qualify if you...

  • Age under 2 years
  • Age over 18 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 night

Participants undergo polysomnography with the BodySleep algorithm and respiratory signal monitoring to identify obstructive sleep apnea.

1 overnight visit (in-person)

Trial Site Locations

Total: 1 location

1

CHRU de Nancy

Nancy, Grand Est, France, 54000

Actively Recruiting

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Research Team

I

Iulia-Cristina IOAN, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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.

Sarah Dietz-Terjung, Amelie Ricarda Martin, Eysteinn Finnsson...

https://pubmed.ncbi.nlm.nih.gov/33594617