Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis.

NCT06474143 | Completed

• 2 other identifiers: C23-802023-A02144-41
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the ability of the Apneal application in diagnosing sleep apnea in adult patients. Participants will be asked to wear the Apneal device during their fulll-night sleep test (polysomnography, the gold standard for sleep apnea)

Conditions

Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• Performance of Apneal® in categorizing SAHS severity using AHI

  The primary endpoint of this study is the performance of Apneal® in categorizing SAHS severity in four classes compared to PSG: normal (AHI \< 5), mild (5 ≤ AHI \< 15), moderate (15 ≤ AHI \< 30), and severe (AHI ≥ 30)

  through study completion, an average of 1 year

Secondary Outcomes (16)

• Correlation between AHI from Apneal and AHI from PSG

  through study completion, an average of 1 year

• Correlation between AHI from Apneal and AHI from nocturnal polygraphy

  through study completion, an average of 1 year

• Correlation between AHI from apneal and ODI from nocturnal oximetry

  through study completion, an average of 1 year

• Correlation between AHI from Apneal and NoSAS score

  through study completion, an average of 1 year

• Correlation between AHI from Apneal and STOPBANG score

  through study completion, an average of 1 year

Study Arms (1)

Epxerimental

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

Epxerimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals, men or women, aged over 18 and with no upper age limit;
• Individuals for whom PSG is indicated as part of routine care, regardless of indication.
• Individuals willing and able to comply with study requirements;
• Individuals with a declared total sleep time of at least 6 hours, as recommended by AASM for PSG analysis.
• Individuals affiliated to social security or beneficiary of such a scheme if applicable according to the local regulation ;
• Voluntary individuals who have provided oral and written consent after being informed by the research investigator.

You may not qualify if:

• Individuals with active implantable medical devices (e.g. electronic heart implant, electrical neurophysiological stimulator…);
• Individuals with mechanical heart valves;
• Individuals with chest deformity preventing the phone to be correctly placed on the chest
• Individuals with uncontrolled psychiatric conditions impairing their ability to fully consent to the study
• Individuals suffering from epilepsy or an associated disorder;
• Individuals suffering from a moderate to severe valvular disease;
• Individuals under CPAP treatment during the participation.
• Individuals suffering from a nervous system disorder that causes unintended or uncontrollable movements, other than periodic leg movement syndrome and restless leg syndrome.
• Refusal to participate in the study at any time during the clinical investigation;
• Individuals not able to understand and speak the official language of the research center;
• Vulnerable individuals according to local legislation

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Centre du sommeil, hôpital Bichat

Paris, France

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Polysomnography results not available to device
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: June 25, 2024
• Study Start: February 28, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)