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Enhanced Respiratory Polygraphy in Suspected OSA

NCT05949853 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-11-13

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-01
Completion
2023-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949853 on ClinicalTrials.gov