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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMitral

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) 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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Apneal device

    Device

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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

Concordance of AHI measured by Apneal® with AHI measured by PSG, and the mean absolute error between the two measurements.

Time frame
through study completion, an average of 1 year
2

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

Comparison of Apneal®'s performance with the NoSAS, Berlin, and Epworth questionnaires in classifying the severity of SAHS into the four categories (normal, mild, moderate, severe) relative to PSG.

Time frame
through study completion, an average of 1 year
3

Detect sleep stages using Apneal®

The minimum concordance between Apneal® and PSG for both sleep stage durations (wake, REM, NREM: N1, N2, N3) and sleep stage latencies.

Time frame
through study completion, an average of 1 year
4

Differentiate central and obstructive apneas using Apneal®

Estimation of the Central Apnea Index (CAI) by Apneal® compared to PSG, indicating the number of central apneas per hour of sleep.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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