Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Polysomnography in routine care | Children 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.