Enhanced Respiratory Polygraphy in Suspected OSA

NCT05949853 | Unknown

• 1 other identifier: 69HCL23_0238
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Polysomnography; Polygraphy; single channel EEG automated sleep scoring

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Other: the respiratory parameters (AHI) and time spent

Interventions

the respiratory parameters (AHI) and time spent 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)

Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients Hospitalized at the Center for Sleep Medicine and Respiratory Diseases

You may qualify if:

• \- 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de médecine du sommeil et des maladies respiratoires

Lyon, 69004, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-07

Locations

FR (1)