Sleep Apnea Syndromes
Conditions
Brief 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.
Interventions
DEVICEApneal device
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography
Sponsors
Mitral
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Each patient will wear the device and polysomnograph at the same time
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals, male or female, aged 18 years or older (no upper age limit). * Individuals for whom polysomnography (PSG) is indicated as part of routine care, regardless of the specific indication. * Individuals with a reported total sleep time of at least 6 hours, in accordance with AASM recommendations for PSG analysis. * Individuals affiliated with social security or benefiting from a similar system, if applicable, in accordance with local regulations. * Voluntary individuals who have provided oral and written consent after being informed by the research investigator.
Exclusion criteria
* Individuals with an active implantable medical device (e.g., electronic cardiac implant, neurophysiological electrical stimulator). * Individuals with a chest deformity that prevents proper placement of the smartphone on the chest. * Individuals with uncontrolled psychiatric disorders that prevent them from giving full consent to the study. * Individuals unable to understand or speak the official language of the research center. * Individuals currently excluded from another protocol or participating in another interventional research study. * Vulnerable persons or adults under legal protection, including pregnant or breastfeeding women, persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent, or admitted for purposes other than research (Articles L1121-5 to L1121-8 of the French Public Health Code).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS) | through study completion, an average of 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth) | through study completion, an average of 1 year | 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. |
| Detect sleep stages using Apneal® | through study completion, an average of 1 year | The minimum concordance between Apneal® and PSG for both sleep stage durations (wake, REM, NREM: N1, N2, N3) and sleep stage latencies. |
| Differentiate central and obstructive apneas using Apneal® | through study completion, an average of 1 year | Estimation of the Central Apnea Index (CAI) by Apneal® compared to PSG, indicating the number of central apneas per hour of sleep. |
| Estimate the Apnea-Hypopnea Index (AHI) using Apneal® | through study completion, an average of 1 year | Concordance of AHI measured by Apneal® with AHI measured by PSG, and the mean absolute error between the two measurements. |
| Evaluate patient acceptability of Apneal® | through study completion, an average of 1 year | Percentage of patients who agree to participate vs. those who refuse, including reasons for refusal (e.g., equipment-related issues, cognitive impairment). |
| Assess the feasibility of SAHS screening using Apneal® | through study completion, an average of 1 year | 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. |
| Detect patient movements with Apneal® | through study completion, an average of 1 year | Comparison of night segmentation by movements (presence/absence) between Apneal® and PSG, and evaluation of the number of movements detected by both. |
Countries
France
Contacts
Primary ContactGuillaume Cathelain, PhD
Backup ContactLola Martin
Outcome results
None listed