Sleep Apnea SyndromesAMELIASNCT06141967
Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment
A study testing WITHINGS Sleep Analyzer in people with Sleep Apnea Syndromes and Metabolic Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Metabolic Syndrome, Diabetes
- What is being tested?
- WITHINGS Sleep Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2023to 9 Jul 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
- Adult patients over 18 years old
- Diabetes Mellitus (Type 1 or 2), or obesity (BMI>30kg/m²) or metabolic syndrome
- Hospitalized for at least one night in the Endocrinology department
- Affiliated or entitled to a social security scheme
- Having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study
Who cannot join
- Known and/or treated OSAS-type respiratory pathology
- No signature of the informed consent form
- Minor or adult patients under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.
Read the detailed description
There is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. The investigators would like to test a new organization of care to facilitate and intensify this screening.
- Conditions
- Sleep Apnea Syndromes, Metabolic Syndrome, Diabetes, Obese
- Being tested
- WITHINGS Sleep Analyzer
- Keywords
- Sleep Apnea Syndromes, Diabetes, Withings Sleep analyzer, Epworth, Berlin
- Medical subject headings
- Sleep Apnea Syndromes, Metabolic Syndrome, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WITHINGS Sleep AnalyzerDevice
Also called WSA
Potentially eligible patients will be offered to participate in the study, the information leaflet will be given to them and the informed consent form will be signed if the patient agrees to participate in the study.
In hospitalization in Endocrinology:
- Realization of the current care report
- Including systematic achievement of EPWORTH and BERLIN scores
- Activation of the WSA throughout the duration of the hospitalization
- Completion of a feasibility questionnaire for the team
- Quantification of the non-usable screening technique
- Completion of a patient experience questionnaire at the end of the stay
- In the event of published positive criteria either for the BERLIN questionnaires, EPWORTH questionnaires or WSA, the patient will be referred to the VISAS center for definitive diagnostic evaluation by polygraphy or polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| WITHINGS Sleep Analyzer | Experimental | The sleep apnea screening device used is a medical screening device WITHINGS Sleep Analyzer (WSA) Receives: Device: WITHINGS Sleep Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients real positive for each screening technique
Percentage of patients real positive for each screening technique: BERLIN and EPWORTH score and Withings Sleep Analyzer addressed for polysomnography
Measured: Day 2
Secondary outcomes (3)
Number of tests
Number of positive tests / Number of analyzable test for screening for each type of test
Measured: Day 2
Patient's experience with the use of Withings Sleep Analyzer
Patients' experience is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.
Measured: Day 2
Nurse's satisfaction with the use of Withings Sleep Analyzer
Nurse's satisfaction is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start30 Nov 2023
- Primary completion19 Feb 2025
- Study completion9 Jul 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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natacha GERMAIN, MD-PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141967
- Sponsor's protocol ID
- 23CH133
- Other IDs
- ANSM
- Acronym
- AMELIAS
- Status last verified
- Jul 2025
- First submitted
- 9 Nov 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment
- ClinicalTrials.gov ID
- NCT06141967
- Acronym / sponsor ID
- AMELIAS / 23CH133
- Conditions
- Sleep Apnea Syndromes, Metabolic Syndrome, Diabetes, Obese
- Keywords
- Sleep Apnea Syndromes, Diabetes, Withings Sleep analyzer, Epworth, Berlin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 21 Nov 2023 (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.
Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.
Detailed description
There is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. The investigators would like to test a new organization of care to facilitate and intensify this screening.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WITHINGS Sleep Analyzer | Experimental | Device: WITHINGS Sleep AnalyzerThe sleep apnea screening device used is a medical screening device WITHINGS Sleep Analyzer (WSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients over 18 years old
- Diabetes Mellitus (Type 1 or 2), or obesity (BMI>30kg/m²) or metabolic syndrome
- Hospitalized for at least one night in the Endocrinology department
- Affiliated or entitled to a social security scheme
- Having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study
Key exclusion criteria (3 listed)
- Known and/or treated OSAS-type respiratory pathology
- No signature of the informed consent form
- Minor or adult patients under guardianship or curatorship
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 |
|---|---|---|
| WITHINGS Sleep AnalyzerAlso: WSAPotentially eligible patients will be offered to participate in the study, the information leaflet will be given to them and the informed consent form will be signed if the patient agrees to participate in the study. In hospitalization in Endocrinology: * Realization of the current care report * Including systematic achievement of EPWORTH and BERLIN scores * Activation of the WSA throughout the duration of the hospitalization * Completion of a feasibility questionnaire for the team * Quantification of the non-usable screening technique * Completion of a patient experience questionnaire at the end of the stay * In the event of published positive criteria either for the BERLIN questionnaires, EPWORTH questionnaires or WSA, the patient will be referred to the VISAS center for definitive diagnostic evaluation by polygraphy or polysomnography. | Device | WITHINGS Sleep Analyzer |
Primary outcome
patients real positive for each screening technique
Time frame: Day 2
Percentage of patients real positive for each screening technique: BERLIN and EPWORTH score and Withings Sleep Analyzer addressed for polysomnography
3 secondary outcomes
Number of tests
Time frame: Day 2
Patient's experience with the use of Withings Sleep Analyzer
Time frame: Day 2
Nurse's satisfaction with the use of Withings Sleep Analyzer
Time frame: 3 months
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 18 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Natacha GERMAIN, MD-PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WITHINGS Sleep Analyzer in people with Sleep Apnea Syndromes and Metabolic Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 3 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 18 Jul 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?
patients real positive for each screening technique (time frame: Day 2). 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 18 Jul 2025.