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Recruiting NCT06578390

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

No phase Interventional Sleep Apnea Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apneal device.
Who it may be relevant to
Registry conditions: Sleep Apnea Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS) [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (7)
  • Estimate the Apnea-Hypopnea Index (AHI) using Apneal® [Time frame: through study completion, an average of 1 year]
  • Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth) [Time frame: through study completion, an average of 1 year]
  • Detect sleep stages using Apneal® [Time frame: through study completion, an average of 1 year]
  • Differentiate central and obstructive apneas using Apneal® [Time frame: through study completion, an average of 1 year]
  • Detect patient movements with Apneal® [Time frame: through study completion, an average of 1 year]
  • Evaluate patient acceptability of Apneal® [Time frame: through study completion, an average of 1 year]
  • Assess the feasibility of SAHS screening using Apneal® [Time frame: through study completion, an average of 1 year]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 11 centers
  • Centre de pneumologie et sommeil — Aix-en-Provence
  • Centre du sommeil d'Antony — Antony
  • Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air — Bordeaux
  • SomnoLab - Millénaire — Montpellier
  • Cabinet de médecine du sommeil - Cabsom — Mulhouse
  • Somnology — Paris
  • Institut médical du sommeil — Paris
  • Cabinet privé du Dr. Wanono — Reims
  • … and 3 more centers

Identifiers

NCT: NCT06578390 · 2024-A00042-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗