Pediatric Obstructive Sleep Apnea Diagnosis by Respiratory Polygraphy

Not yet recruiting

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT06754800
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Respiratory polygraphy (RP) can be used to detect obstructive sleep apnea syndrome in children (OSA) , but it underestimates the obstructive apnea-hypopnea index (OAHI) because hypopneas associated with cortical arousals are not evaluated. To compensate for this disadvantage, hypopneas linked with autonomic micro-arousals can be calculated from the drop in pulse wave amplitude (obtained dy oximetry), as increased respiratory efforts are related to autonomic nervous system activation, tachycardia, and elevated blood pressure.

The aim of this study is to compare OAHI obtained by RP alone or by RP considering hypopneas associated with autonomic micro-arousals with OAHI by polysomnography (PSG).

Detailed Description

The diagnosis of obstructive sleep apnea syndrome in children (OSA) requires to perform a polysomnography (PSG) in hospitalization 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 difficult to perform in children, with several sensors and electrodes to install.

Respiratory polygraphy (RP) which uses only respiratory signals (without the neurophysiological signals ) can be used for the diagnosis of OSA but it underestimates OAHI because the hypopneas associated with cortical micro-arousals are not taken into account. An alternative to overcome this disadvantage is to determine the presence of autonomic micro-arousals because the increase in respiratory efforts during sleep is associated with activation of the autonomic nervous system and cardiovascular effects, such as tachycardia and an increase in blood pressure. Consequently, these respiratory efforts are associated either with autonomic activation or with cortical micro-arousal. One method to determine autonomic micro-arousals is photo-plethysmography which reflects sympathetic activation. Photoplethysmography is obtained by oximetry signal and is a non-invasive technique based on measuring the relative absorption by the blood of red light and infrared light through the finger. The pulsation of arterial blood flow through the finger arteries modulates light absorption and generates a pulse wave signal.

Autonomic micro-arousals will be calculated according to 3 algorithms: reduction of 1) 30%; 2) 40%; 3) 50% of the photoplethysmography signal compared to the baseline and the hypopneas associated with these decreases will be taken into account in the calculation of the OAHI. Consequently, 3 OAHI will be obtained by RP including hypopneas associated with autonomic micro-arousals.

The aim of this study is to compare OAHI obtained by RP considering hypopneas associated with autonomic micro-arousals with OAHI by PSG.

The hypothesis of this study is that RP by adding hypopneas associated with autonomic micro-arousals can identify OSA in children.

Study Timeline

• Study First Submitted: 2024-03-15
• Status Verified: 2024-12
• Study Start: 2024-12-22
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Primary Completion: 2024-12-28
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Study Completion: 2025-01-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Children with suspicion of OSA
• Interpretable polysomnography

Exclusion Criteria

• Non-interpretable polysomnography

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OAHI in RP including hypopneas associated with autonomic micro-arousals correlated with OAHI by PSG	A single night	Value of OAHI in RP including hypopneas associated with autonomic micro-arousals obtained by 3 algorithms (3 values of OAHI) correlated with OAHI by PSG

Secondary Outcome Measures

Name	Time	Method
Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose OSA reported to PSG	A single night	Sensitivity and specificity of the OAHI obtained by RP including hypopneas associated with autonomic micro-arousals to identify OSA in children
Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose moderate-severe OSA reported to PSG	A single night	Sensitivity and specificity of the OAHI obtained by RP including hypopneas associated with autonomic micro-arousals to identify moderate-severe OSA in children
Determine the best of the 3 algorithms that better correlates with OAHI by PSG	A single night	Comparison between the 3 correlation coefficients obtained from the correlation between value of OAHI in RP including hypopneas associated with autonomic micro-arousals obtained by 3 algorithms (3 values of OAHI) and OAHI by PSG

Trial Locations

Locations (1)

University Hospital of Nancy; 🇫🇷 Nancy, France