Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
NCT Number: NCT06578390
Acronym: SESAME
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Apnea Syndromes
Interventions: DEVICE: Apneal device
Sponsor: Mitral
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-26
Completion Date: 2025-04-30
Locations: Centre de pneumologie et sommeil, Aix-en-Provence, 13290, France|Centre du sommeil d'Antony, Antony, 92160, France|Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air, Bordeaux, 33200, France|SomnoLab - Millénaire, Montpellier, 34000, France|Cabinet de médecine du sommeil - Cabsom, Mulhouse, 68200, France|Somnology, Paris, 75015, France|Institut médical du sommeil, Paris, 75116, France|Cabinet privé du Dr. Wanono, Reims, 51100, France|Clinique du Renaison, Roanne, 42300, France|Somnidoc, Roanne, 42300, France|Centre Clinical, Soyaux, 16800, France

Summary:
The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care. The main questions it aims to answer are:

* Can Apneal® accurately classify the SAS severity into four categories (normal: AHI \< 5, mild: 5 ≤ AHI \< 15, moderate: 15 ≤ AHI \< 30, and severe: AHI ≥ 30) compared to PSG ?
* How does Apneal® perform in estimating the Apnea-Hypopnea Index (AHI), detecting sleep stages, differentiating between central and obstructive apneas, and identifying patient movements?

Participants will:

* Wear the Apneal® app-equipped smartphone and undergo PSG during a full night of sleep at home.
* Complete several questionnaires assessing sleep symptoms and experience with the Apneal® app.

Primary Outcome Measures: Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS), Performance of Apneal® in classifying the severity of SAHS into four categories (normal: AHI \< 5, mild: 5 ≤ AHI \< 15, moderate: 15 ≤ AHI \< 30, severe: AHI ≥ 30) compared to polysomnography (PSG)., through study completion, an average of 1 year
Secondary Outcome Measures: Estimate the Apnea-Hypopnea Index (AHI) using Apneal®, Concordance of AHI measured by Apneal® with AHI measured by PSG, and the mean absolute error between the two measurements., through study completion, an average of 1 year|Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth), Comparison of Apneal®'s performance with the NoSAS, Berlin, and Epworth questionnaires in classifying the severity of SAHS into the four categories (normal, mild, moderate, severe) relative to PSG., through study completion, an average of 1 year|Detect sleep stages using Apneal®, The minimum concordance between Apneal® and PSG for both sleep stage durations (wake, REM, NREM: N1, N2, N3) and sleep stage latencies., through study completion, an average of 1 year|Differentiate central and obstructive apneas using Apneal®, Estimation of the Central Apnea Index (CAI) by Apneal® compared to PSG, indicating the number of central apneas per hour of sleep., through study completion, an average of 1 year|Detect patient movements with Apneal®, Comparison of night segmentation by movements (presence/absence) between Apneal® and PSG, and evaluation of the number of movements detected by both., through study completion, an average of 1 year|Evaluate patient acceptability of Apneal®, Percentage of patients who agree to participate vs. those who refuse, including reasons for refusal (e.g., equipment-related issues, cognitive impairment)., through study completion, an average of 1 year|Assess the feasibility of SAHS screening using Apneal®, Percentage of patients with usable data provided by Apneal® out of the total number of patients included; data considered unusable if Apneal® is lost during the night., through study completion, an average of 1 year