Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-23
Brief Title:
Video-respiratory Polygraphy in Children
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Video-respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None