Video-respiratory Polygraphy in Children

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287333
• Other study ID #: 2023PI221
• Status: Not yet recruiting
• Start date: February 22, 2024
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Iulia IOAN, MD PhD
• Phone: +33383154794
• Email: ic.ioan[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: February 28, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 19 Years

Eligibility

Inclusion Criteria:

• Children with suspicion of OSAS
• Interpretable polysomnography

Exclusion Criteria:

• Non-interpretable polysomnography

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Polysomnography in routine care
Children performed a polysomnography in routine clinical care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OAHI in video-RP significantly correlated with OAHI in PSG	Value of the OAHI obtained by the video-RP for each of the children in the groups with OSAS (who have an OAHI = 1/h in PSG) and without OSAS (who have an OAHI < 1/h in PSG) will be correlated with the value of OAHI obtained by PSG using a Fisher exact test	One night
Secondary	Diagnostic ability of video-RP to identify OSAS in children	ROC curves to determine the sensitivity and specificity of the OAHI obtained by video-RP to identify children with OSA	One night
Secondary	Diagnostic ability of video-RP to identify moderate-severe OSAS in children	ROC curves to determine the sensitivity and specificity of the OAHI obtained by video-RP to identify children with moderate-severe OSA (with an OAHI = 5 /h in PSG)	One night