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UnknownNCT06287333

Video-respiratory Polygraphy in Children

Video-respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children

Status
Unknown
Phase
Study type
Observational
Enrollment
66 (estimated)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
2 Years – 19 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPolysomnography in routine careChildren performed a polysomnography in routine clinical care

Timeline

Start date
2024-02-22
Primary completion
2024-02-22
Completion
2024-02-28
First posted
2024-03-01
Last updated
2024-03-01

Source: ClinicalTrials.gov record NCT06287333. Inclusion in this directory is not an endorsement.