BodySleep Algorithm for OSA Diagnosis in Children
ConditionObstructive Sleep Apnea of Child
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age under 2 years and over 18 years
Trial population
A retrospective study including children aged 2 to 18 years addressed for a PSG.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Polysomnography
Diagnostic testPSG performed prospectively in routine care in children suspected of OSA
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Obstructive apnea-hypopnea index by BodySleep in comparison with OAHI by PSG
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
Time frame
One nightSponsors and contacts
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Source ClinicalTrials.gov