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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
500
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography
Centre de pneumologie et sommeil
Aix-en-Provence, France
RECRUITINGCentre du sommeil d'Antony
Antony, France
RECRUITINGPôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air
Bordeaux, France
RECRUITINGSomnoLab - Millénaire
Montpellier, France
NOT_YET_RECRUITINGCabinet de médecine du sommeil - Cabsom
Mulhouse, France
RECRUITINGSomnology
Paris, France
RECRUITINGInstitut médical du sommeil
Paris, France
NOT_YET_RECRUITINGCabinet privé du Dr. Wanono
Reims, France
RECRUITINGClinique du Renaison
Roanne, France
RECRUITINGSomnidoc
Roanne, France
RECRUITING...and 1 more locations
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).
Time frame: through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: through study completion, an average of 1 year
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