Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis

NCT06578390 | Recruiting

• 1 other identifier: 2024-A00042-45
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 11

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.

Conditions

Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• 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).

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Estimate the Apnea-Hypopnea Index (AHI) using Apneal®

  through study completion, an average of 1 year

• Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth)

  through study completion, an average of 1 year

• Detect sleep stages using Apneal®

  through study completion, an average of 1 year

• Differentiate central and obstructive apneas using Apneal®

  through study completion, an average of 1 year

• Detect patient movements with Apneal®

  through study completion, an average of 1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Patients will wear the device during their polysomnographic recording

Device: Apneal device

Interventions

Apneal device DEVICE

Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mitral: lead

Study Sites (11)

Centre de pneumologie et sommeil

Aix-en-Provence, 13290, France

RECRUITING

Centre du sommeil d'Antony

Antony, 92160, France

RECRUITING

Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air

Bordeaux, 33200, France

RECRUITING

SomnoLab - Millénaire

Montpellier, 34000, France

NOT YET RECRUITING

Cabinet de médecine du sommeil - Cabsom

Mulhouse, 68200, France

RECRUITING

Somnology

Paris, 75015, France

RECRUITING

Institut médical du sommeil

Paris, 75116, France

NOT YET RECRUITING

Cabinet privé du Dr. Wanono

Reims, 51100, France

RECRUITING

Clinique du Renaison

Roanne, 42300, France

RECRUITING

Somnidoc

Roanne, 42300, France

RECRUITING

Centre Clinical

Soyaux, 16800, France

NOT YET RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ruben Wanono, MD

  CHU de Reims

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Cathelain, PhD

CONTACT

+33672448711; guillaume.cathelain@apneal.ai

Lola Martin

CONTACT

+33744475942; lola.martin@stane-groupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each patient will wear the device and polysomnograph at the same time

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 29, 2024
• Study Start: March 26, 2024
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)