Clinical trial NCT06578390: Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Official title: Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea Syndromes
Lead sponsor: Mitral
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will wear the device and polysomnograph at the same time
Primary purpose: DIAGNOSTIC

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.


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 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).

Primary outcomes:
measure: Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Estimate the Apnea-Hypopnea Index (AHI) using Apneal®
timeFrame: through study completion, an average of 1 year
measure: Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth)
timeFrame: through study completion, an average of 1 year
measure: Detect sleep stages using Apneal®
timeFrame: through study completion, an average of 1 year
measure: Differentiate central and obstructive apneas using Apneal®
timeFrame: through study completion, an average of 1 year
measure: Detect patient movements with Apneal®
timeFrame: through study completion, an average of 1 year
measure: Evaluate patient acceptability of Apneal®
timeFrame: through study completion, an average of 1 year
measure: Assess the feasibility of SAHS screening using Apneal®
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre de pneumologie et sommeil
city: Antony
country: France
facility: Centre du sommeil d'Antony
city: Bordeaux
country: France
facility: Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air
city: Montpellier
country: France
facility: SomnoLab - Millénaire
city: Mulhouse
country: France
facility: Cabinet de médecine du sommeil - Cabsom
city: Paris
country: France
facility: Somnology
city: Paris
country: France
facility: Institut médical du sommeil
city: Reims
country: France
facility: Cabinet privé du Dr. Wanono
city: Roanne
country: France
facility: Clinique du Renaison
city: Roanne
country: France
facility: Somnidoc
city: Soyaux
country: France
facility: Centre Clinical
Study officials:
affiliation: CHU de Reims
name: Ruben Wanono, MD
role: PRINCIPAL_INVESTIGATOR
References: