Clinical trial NCT06474143: Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis.
Official title: Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis studY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2024-06-25
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will wear the device and polysomnograph at the same time
Primary purpose: DIAGNOSTIC

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)


Eligibility criteria: 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

Primary outcomes:
measure: Performance of Apneal® in categorizing SAHS severity using AHI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Correlation between AHI from Apneal and AHI from PSG
timeFrame: through study completion, an average of 1 year
measure: Correlation between AHI from Apneal and AHI from nocturnal polygraphy
timeFrame: through study completion, an average of 1 year
measure: Correlation between AHI from apneal and ODI from nocturnal oximetry
timeFrame: through study completion, an average of 1 year
measure: Correlation between AHI from Apneal and NoSAS score
timeFrame: through study completion, an average of 1 year
measure: Correlation between AHI from Apneal and STOPBANG score
timeFrame: through study completion, an average of 1 year
measure: Correlation between AHI from Apneal and Berlin score
timeFrame: through study completion, an average of 1 year
measure: Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score
timeFrame: through study completion, an average of 1 year
measure: The classification of sleep epochs into three categories : wake, REM sleep and NREM sleep (N1, N2 or N3).
timeFrame: through study completion, an average of 1 year
measure: The segmentation of the night in snores and non-snores periods
timeFrame: through study completion, an average of 1 year
measure: Heart rate
timeFrame: through study completion, an average of 1 year
measure: Autonomic sleep fragmentation
timeFrame: through study completion, an average of 1 year
measure: Central apnea index
timeFrame: through study completion, an average of 1 year
measure: Position detection
timeFrame: through study completion, an average of 1 year
measure: Wake/night detection
timeFrame: through study completion, an average of 1 year
measure: Medicoeconomic study
timeFrame: through study completion, an average of 1 year
measure: Medicoeconomic study
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre du sommeil, hôpital Bichat
Study officials:
References: