Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Mitral
500 participants
Mar 26, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06578390