Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Recruiting
N/A
Interventional Study
Sleep Apnea Syndromes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 500 (estimated)
- Sponsor
- Mitral · Industry
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About This Trial
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) com…
Trial Locations
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Eligibility Criteria
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…
Contacts