Sleep Apnea SyndromesEASYNCT06474143
Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis.
A study testing Apneal device in people with Sleep Apnea Syndromes, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Apneal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis studY
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
- Being tested
- Apneal device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneal deviceDevice
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography
| Study group | Role | What they receive |
|---|---|---|
| Epxerimental | Experimental | Patients will wear the device during their polysomnographic recording Receives: Device: Apneal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (16)
Correlation between AHI from Apneal and AHI from PSG
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.
Measured: through study completion, an average of 1 year
Correlation between AHI from Apneal and AHI from nocturnal polygraphy
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.
Measured: through study completion, an average of 1 year
Correlation between AHI from apneal and ODI from nocturnal oximetry
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.
Measured: through study completion, an average of 1 year
Correlation between AHI from Apneal and NoSAS score
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.
Measured: through study completion, an average of 1 year
Correlation between AHI from Apneal and STOPBANG score
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.
Measured: through study completion, an average of 1 year
Correlation between AHI from Apneal and Berlin score
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.
Measured: through study completion, an average of 1 year
Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score
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.
Measured: through study completion, an average of 1 year
The classification of sleep epochs into three categories : wake, REM sleep and NREM sleep (N1, N2 or N3).
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.
Measured: through study completion, an average of 1 year
The segmentation of the night in snores and non-snores periods
Segmentations of Apneal® and manual scoring of the recorded sound, by a sleep technologist in the centralized scoring center, will be compared.
Measured: through study completion, an average of 1 year
Heart rate
The heart rate predicted by Apneal®, compared with the heart rate derived from ECG on PSG.
Measured: through study completion, an average of 1 year
Autonomic sleep fragmentation
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.
Measured: through study completion, an average of 1 year
Central apnea index
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.
Measured: through study completion, an average of 1 year
Position detection
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.
Measured: through study completion, an average of 1 year
Wake/night detection
The segmentation of the night as wake and sleep predicted by Apneal® and manually scored on PSG will be compared.
Measured: through study completion, an average of 1 year
Medicoeconomic study
The estimated relative difference between the costs of visits, with and without Apneal® in the clinical pathway
Measured: through study completion, an average of 1 year
Medicoeconomic study
The estimated relative difference between the number of visits, with and without Apneal® in the clinical pathway
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start28 Feb 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will wear the device and polysomnograph at the same time
- Masking
- None (open label)
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474143
- Sponsor's protocol ID
- C23-80
- Other IDs
- 2023-A02144-41
- Acronym
- EASY
- Status last verified
- Sep 2025
- First submitted
- 7 Feb 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis studY
- ClinicalTrials.gov ID
- NCT06474143
- Acronym / sponsor ID
- EASY / C23-80
- Conditions
- Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will wear the device and polysomnograph at the same time
| Arm | Type | Receives |
|---|---|---|
| Epxerimental | Experimental | Device: Apneal devicePatients will wear the device during their polysomnographic recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 ;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apneal devicePatients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography | Device | Epxerimental |
Primary outcome
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)
16 secondary outcomes
Correlation between AHI from Apneal and AHI from PSG
Time frame: through study completion, an average of 1 year
Correlation between AHI from Apneal and AHI from nocturnal polygraphy
Time frame: through study completion, an average of 1 year
Correlation between AHI from apneal and ODI from nocturnal oximetry
Time frame: through study completion, an average of 1 year
Correlation between AHI from Apneal and NoSAS score
Time frame: through study completion, an average of 1 year
Correlation between AHI from Apneal and STOPBANG score
Time frame: through study completion, an average of 1 year
Correlation between AHI from Apneal and Berlin score
Time frame: through study completion, an average of 1 year
Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score
Time frame: through study completion, an average of 1 year
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 segmentation of the night in snores and non-snores periods
Time frame: through study completion, an average of 1 year
Heart rate
Time frame: through study completion, an average of 1 year
Autonomic sleep fragmentation
Time frame: through study completion, an average of 1 year
Central apnea index
Time frame: through study completion, an average of 1 year
Position detection
Time frame: through study completion, an average of 1 year
Wake/night detection
Time frame: through study completion, an average of 1 year
Medicoeconomic study
Time frame: through study completion, an average of 1 year
Medicoeconomic study
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apneal device in people with Sleep Apnea Syndromes, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Apneal® in categorizing SAHS severity using AHI (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.