Enhanced Respiratory Polygraphy in Suspected OSA

NCT ID: NCT05949853

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-01

Brief Summary

Obstructive Sleep Apnea (OSA) remains underdiagnosed in 2022, as a result of the unawareness of its serious health-related consequences and the lack of diagnosis accessibility. Respiratory polygraphy (PV) is widely used as a screening tool and sometimes a diagnosis test, although polysomnography (PSG) remains the gold standard investigation as it provides complete information about sleep architecture and arousals. Thus, it has been shown that the Apnea Hypopnea Index (AHI) and Respiratory Disorder Index (RDI) are underestimated by PV vs PSG. Approaches to substitute PSG by simpler but equally efficient diagnosis tests have included devices aiming to record complementary signals and to analyze them with Artificial Intelligence. In this context, ASEEGA algorithm has demonstrated its performance for automatic sleep scoring in healthy individuals and patients with various sleep disorders, based on a single channel EEG analysis.

This study aims at comparing the real-life performance and feasibility of added single channel EEG automatic sleep scoring using ASEEGA to PV versus standard PV and PSG in adults referred to a regional sleep reference center for suspected OSA.

We hypothesize that this approach (1) is as accurate as PSG and more accurate that PV for AHI analysis, and (2) is less time-consuming than PSG.

Conditions

Sleep Apnea, Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients

Patients hospitalized at the Center for Sleep and Respiratory Diseases, between 09/2022 and 11/2022 for suspected OSA All these patients underwent a full night polysomnography

the respiratory parameters (AHI) and time spent

Intervention Type: OTHER

interpret the recording will be evaluated for PSG, PV and PV+ASEEGA Apnea Hypopnea Index as assessed by PSG (respiratory signals + electro-encephalography + electro-oculography + chin electromyography), PV (respiratory signals) and PV+ASEEGA (respiratory signals + result of sleep stages and arousals scoring by ASEEGA algorithm based on automatic analysis of one EEG Cz-Pz channel)

Interventions

the respiratory parameters (AHI) and time spent

interpret the recording will be evaluated for PSG, PV and PV+ASEEGA Apnea Hypopnea Index as assessed by PSG (respiratory signals + electro-encephalography + electro-oculography + chin electromyography), PV (respiratory signals) and PV+ASEEGA (respiratory signals + result of sleep stages and arousals scoring by ASEEGA algorithm based on automatic analysis of one EEG Cz-Pz channel)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Hospitalized at the Center for Sleep Medicine and Respiratory Diseases, Hôpital de la Croix-Rousse, Lyon Academic Hospital, Lyon between 09/2022 and 11/2022 for PSG following suspected OSA .

Exclusion Criteria

• Unreliable sleep scoring due to artefacts (> 10% of the recording) or to epileptic abnormalities on the electroencephalography recordings
• Presence of other suspected sleep disorder: central hypersomnia, rapid-eye-movement (REM) or non-REM sleep parasomnia, sleep-related motor disorders...
• Ongoing psychotropic medication
• Opposition of the patient to the use of their data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de médecine du sommeil et des maladies respiratoires

Lyon, , France

Countries

France

Other Identifiers

69HCL23_0238

Identifier Type: -

Identifier Source: org_study_id