Clinical trial NCT06287333: Video-respiratory Polygraphy in Children
Official title: Video-respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Apnea, Obstructive
Keywords: child
polysomnography
polygraphy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 2 to 19 years adressed for a PSG in routine clinical care for suspicion of OSAS by the ear-nose-throat physician, pediatric pulmonologist, sleep specialist, endocrinologist, genetician.

Brief summary: The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not.

Detailed description: The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires the performance of a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. PSG gives the obstructive apnea-hypopnea index (OAHI) necessary for the diagnosis of OSA and to determine its severity. But PSG is a cumbersome exam, sometimes difficult to carry out in children, with several sensors and electrodes to install (electroencephalogram (EEG), myogram (EMG), occulogram (EOG), necessary to determine awakening and sleep periods and intra-sleep micro-arousals, nasal cannula, thoraco-abdominal straps, pulse oximetry, actimetry to score respiratory events). PSG is time-consuming for installation and analysis. Simplified methods of recording and analysis are preferable in children but require validation in this population.

Respiratory polygraphy (RP) which uses only respiratory signals (without EEG, EMG and EOG) can be used for the diagnosis of OSA but studies showed that it underestimated the OAHI because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not.

The hypothesis of this study is that video-RP can identify OSAS in children.

Eligibility criteria: Inclusion Criteria:

* Children with suspicion of OSAS
* Interpretable polysomnography

Exclusion Criteria:

* Non-interpretable polysomnography

Primary outcomes:
measure: OAHI in video-RP significantly correlated with OAHI in PSG
timeFrame: One night
Secondary outcomes:
measure: Diagnostic ability of video-RP to identify OSAS in children
timeFrame: One night
measure: Diagnostic ability of video-RP to identify moderate-severe OSAS in children
timeFrame: One night
Other outcomes:
Locations:
Study officials:
References:
citation: Horne AF, Olafsdottir KA, Arnardottir ES. In-person vs video hookup instructions: a comparison of home sleep apnea testing quality. J Clin Sleep Med. 2022 Aug 1;18(8):2069-2074. doi: 10.5664/jcsm.10084.
citation: Sivan Y, Kornecki A, Schonfeld T. Screening obstructive sleep apnoea syndrome by home videotape recording in children. Eur Respir J. 1996 Oct;9(10):2127-31. doi: 10.1183/09031936.96.09102127.