Enhanced Respiratory Polygraphy in Suspected OSA

Sleep Apnea, Obstructive Clinical Trial

— PVa  

Official title:

Enhanced Respiratory Polygraphy (PV_e) Using Single Channel EEG-based Automatic Sleep Scoring in Suspected Obstructive Sleep Apnea: Feasibility and Efficiency as Compared With Polygraphy and Polysomnography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05949853
• Other study ID #: 69HCL23_0238
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Service de médecine du sommeil et des maladies respiratoires	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index as assessed by PSG	Apnea Hypopnea Index will be scored by 2 sleep medical experts at 3 occurrences separated by 1 months interval in a random order (PSG/PV/PV+ASEEGA).; Apnea Hypopnea Index in the three groups (PSG/PV/PV+ASEEGA) will be compared with Friedmann test or one factor ANOVA for paired data, according to data distribution, for each scorer	analysis will start in January 2023 and should be completed after 6 months.