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Completed

NCT Number: NCT06474143

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

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)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre du sommeil, hôpital Bichat

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 in period of exclusion from another protocol or currently participating in another interventional research study;
  • Individuals not able to understand and speak the official language of the research center;
  • Vulnerable individuals according to local legislation

Treatment and study plan

Apneal device

Device

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

Primary outcomes

  1. Performance of Apneal® in categorizing SAHS severity using AHI

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

    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)

Secondary outcomes

  1. Correlation between AHI from Apneal and AHI from PSG

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

    The endpoint requires to assess the performances of Apneal® against PSG first. The ground truth and predicted severities will be established and compared for each included individual.

  2. Correlation between AHI from Apneal and AHI from nocturnal polygraphy

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

    The endpoint requires to assess the performances of Apneal® against polygraphy channels derived from PSG first. The ground truth and predicted severities will be established and compared for each included individual.

  3. Correlation between AHI from apneal and ODI from nocturnal oximetry

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

    The endpoint requires to assess the performances of Apneal®, against nocturnal oximetry, . The ground truth and predicted severities will be established and compared for each included individual.

    The comparison of Apneal® performance with nocturnal oximetry for sleep apnea screening will be conducted using ROC analysis.

  4. Correlation between AHI from Apneal and NoSAS score

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

    The endpoint requires to assess the performances of Apneal® in screening OSAS, against NoSAS . The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods :

    • AHI for Apneal®
    • NoSAS score

    The comparison of Apneal® with NoSAS for sleep apnea screening will be conducted using ROC analysis.

  5. Correlation between AHI from Apneal and STOPBANG score

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

    The endpoint requires to assess the performances of Apneal® in screening OSAS, against NoSAS . The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods :

    • AHI for Apneal®
    • STOPBANG score

    The comparison of Apneal® with STOPBANG for sleep apnea screening will be conducted using ROC analysis.

  6. Correlation between AHI from Apneal and Berlin score

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

    The endpoint requires to assess the performances of Apneal® in screening OSAS, against Berlin questionnaire. The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods :

    • AHI for Apneal®
    • Berlin score

    The comparison of Apneal® with Berlin for sleep apnea screening will be conducted using ROC analysis.

  7. Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score

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

    The endpoint requires to assess the performances of Apneal® in screening OSAS, against Berlin questionnaire. The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods :

    • AHI for Apneal®
    • Epworth sleepiness scale (ESS) score

    The comparison of Apneal® with ESS for sleep apnea screening will be conducted using ROC analysis.

  8. The classification of sleep epochs into three categories : wake, REM sleep and NREM sleep (N1, N2 or N3).

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

    The ground truth (from PSG) and predicted (from Apneal®) sleep stages classification will be established and compared for each included individual after :

    • the PSG and Apneal® data are recorded during the inclusion visit (sleep study)
    • the PSG sleep stages are estimated by the scorer in the centralized center, following AASM guidelines
    • the ground truth sleep stages are output from these estimations or the adjudication committee if there is a disagreement between the two first scorers.
    • Apneal® sleep stages are predicted automatically by the Apneal® algorithm. Sleep stages from Apneal® and PSG are compared using accuracy of the binary classifications.

  9. The segmentation of the night in snores and non-snores periods

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

    Segmentations of Apneal® and manual scoring of the recorded sound, by a sleep technologist in the centralized scoring center, will be compared.

  10. Heart rate

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

    The heart rate predicted by Apneal®, compared with the heart rate derived from ECG on PSG.

  11. Autonomic sleep fragmentation

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

    The autonomic sleep fragmentation index, which is the average amount of autonomic arousals per hour of sleep. It will be estimated by Apneal® and compared with the autonomic sleep fragmentation index derived from ECG on PSG.

  12. Central apnea index

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

    amount of central apneas per hour of sleep. Apneal® will estimate this index, and it will be compared with the central apnea index measured on PSG.

  13. Position detection

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

    The segmentation of the participant's position in 6 categories: supine, left, right, prone, sitting and standing. Segmentation of Apneal® and PSG will be compared. position on PSG will be manually scored, position on Apneal is predicted automatically by the Apneal® algorithm.

  14. Wake/night detection

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

    The segmentation of the night as wake and sleep predicted by Apneal® and manually scored on PSG will be compared.

  15. Medicoeconomic study

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

    The estimated relative difference between the costs of visits, with and without Apneal® in the clinical pathway

  16. Medicoeconomic study

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

    The estimated relative difference between the number of visits, with and without Apneal® in the clinical pathway

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

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

Acronym: EASY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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