Sleep ApneaNCT05197855
Sleep Quality Evolution: Dreem Under CPAP
A study testing Deem 3 Headband in people with Sleep Apnea and Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Continuous positive airway pressure (CPAP) has a caricatural effect in reducing nocturnal respiratory abnormalities and improving the micro-and macrostructure of sleep. Studies characterizing the improvement of acute sleep parameters after the initiation of CPAP are limited to one or two nights of polysomnographic… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Sleep Apnea, Obstructive Sleep Apnea
- What is being tested?
- Deem 3 Headband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2022to 13 Apr 2026
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients newly diagnosed with OSA requiring CPAP treatment
- Patients able to use a mobile application on a smartphone or tablet
- Patients with access to a wi-fi internet connection at home
- Patients agreeing to remote monitoring of CPAP compliance data by the home care provider
- Patients who have signed consent to participate in the study
- Subjects affiliated to a social security
Who cannot join
- Patients already treated for OSA
- Patients treated with a sleep aid (sleeping medications)
- Patients with severe chronic obstructive or restrictive lung disease with or without oxygen
- Patients with unstable cardiovascular disease or severe heart failure requiring hospitalization within the last three months or meeting New York Heart Association criteria, Class III or IV disease
- Subjects listed in articles L1121-5 to L1121-8: pregnant women, feeding and parturients, subjects deprived of liberty by judicial or administrative decision, persons under legal protection
- Persons in a period of exclusion from another study or ongoing participation in a drug study
- Subjects likely, at the investigator's discretion, to be uncooperative or noncompliant with the obligations inherent to participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Sleep Quality During the Initiation of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome: An Exploratory Study
Continuous positive airway pressure (CPAP) has a caricatural effect in reducing nocturnal respiratory abnormalities and improving the micro-and macrostructure of sleep. Studies characterizing the improvement of acute sleep parameters after the initiation of CPAP are limited to one or two nights of polysomnographic recording. This is related to the cost of performing these studies with repeated recordings in the laboratory and to the acceptability by patients to perform multiple nights of recordings.
Investigators currently have powerful and reliable methods allowing us to carry out nights at home in the patient's ecosystem, in real-life conditions. The characterization of sleep parameters by these methods is equivalent to a polysomnographic recording.
Read more
These technological innovations will allow us to characterize sleep before the initiation of CPAP treatment during several nights performed at home. Investigators will then be able to characterize the kinetics and stability of the improvement of sleep parameters in patients with obstructive sleep apnea syndrome in whom continuous positive airway pressure is initiated.
These data will be original and will serve as exploratory data to judge whether the objective improvement of sleep parameters in the first weeks of treatment is associated with improvement in sleepiness, quality of life, and compliance with treatment.
Read the detailed description
This study aims to evaluate the quality of sleep, principally the deep slow-wave sleep (sleep stage N3) before and after the initiation of continuous positive airway pressure (CPAP) treatment.
70 newly diagnosed patients with OSA requiring CPAP treatment, will be included.
For the study, they will wear the Dreem 3 headband and pulse oximeter at home before initiation of CPAP (for 7 nights) and during the first month of CPAP (for a minimum of 9 nights). They will be also equipped with a glucose sensor and a pedometer during the entire study period before and after CPAP treatment.
Patients will also complete questionnaires about their health status before CPAP treatment (at inclusion) and after one month of treatment
These devices will allow the measurements of different parameters: sleep stages, total sleep time, sleep measures derived from sleep stages, snoring, breathing rate, heart rate head movements, arterial hemoglobin oxygen saturation, pulse rate, continuous subcutaneous glucose level, and physical activity data (average daily steps, average distance walked per day).
This will generate interesting data on the sleep parameters and their evolution during the initiation of the CPAP treatment.
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea
- Being tested
- Deem 3 Headband
- Keywords
- Continuous Positive Airway Pressure (CPAP), Technological innovations, Sleep Stages, Dreem Headband
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deem 3 HeadbandDevice
The patient will wear the Dreem 3 headband and pulse oximeter at home before initiation of CPAP (for 7 nights) and during a month of treatment (for a minimum of 9 nights), after the initiation of CPAP. He will also wear a glucose sensor and a pedometer during the entire study period before and after CPAP treatment.
| Study group | Role | What they receive |
|---|---|---|
| Technological innovations and CPAP | Experimental | Patients will be equipped with 4 devices: a Dreem 3 Headband, a pulse oximeter, a continuous glucose sensor, and a pedometer. In parallel they will be equipped by the CPAP at home by Icadom. Receives: Device: Deem 3 Headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment.
Time spent on the deep slow-wave sleep stage (stage N3 sleep), recorded by the Dreem 3 headband, from 7 nights before and 9 nights after initiation of CPAP treatment
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Secondary outcomes (19)
Duration of the other sleep stages (W, N1, N2 and REM)
Sleep stages (W, N1, N2 and REM) and total sleep time spent in each sleep stage, recorded by the Dreem 3. All the data units are in minutes
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Duration of different sleep times
Sleep parameters recorded by Dreem 3 headband: sleep times (bedtime, total sleep time (TST), sleep onset delay (SOD),time in bed (TIB), time awake after falling asleep (WASO), final wakefulness time)
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The percentage of time while sleeping
Sleep parameter recorded by Dreem 3 headband: sleep efficiency ((TST/TIB) x100)
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The frequences of sleep waves during the NREM sleep stage recorded by Dreem 3 headband
sleep spindle density expressed in Hertz recorded by the EEG sensors
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The frequence of snoring while sleeping recorded by Dreem 3 headband
snoring is expressed in decibel minute recorded by a microphone integrated in the Dreem3
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Respiratory rate measurment recorded by Dreem 3 headband
It is expressed in breathe per minute recorded accelerometer sensor
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Heart rate measurement while sleepingrecorded by Dreem 3 headband
Expressed in beats per minute recorded by accelerometer sensor
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The position of the head changes while sleeping recorded by Dreem 3 headband
Head movements are recorded by an accelerometer sensor in the Dreem 3 Headband
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Evolution of the nocturnal oximetry
Nocturnal oxygen saturation measured by a pulse oximeter
Measured: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Evolution of the subcutaneous glucose level
Continuous subcutaneous glucose level (measured by FreeStyle Libre 2 continuous glucose sensor)
Measured: 7 nights before CPAP initiation and for a month after CPAP initiation
Evolution of glycemia
Blood glucose level by blood sampling
Measured: At inclusion and a month after CPAP initiation
Average daily number of steps
It will be measured by a Garmin Vivofit 3 pedometer expressed in steps/day
Measured: 7 nights before CPAP initiation and for a month after CPAP initiation
Average distance walked per day
It will be measured by a Garmin Vivofit 3 pedometer expressed in Kilometer
Measured: 7 nights before CPAP initiation and for a month after CPAP initiation
Sleep quality assessed by Pittsburg questionnaire
The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Measured: At inclusion and a month after CPAP initiation
Severity of insomnia measured by the index sverety of insomnia questionnaire
The general ISI score varies between 0 and 28: -7 = No insomnia 8-14 = Sub-clinical insomnia (mild) 15-21 = Clinical insomnia (moderate) 22-28 = Clinical insomnia (severe)
Measured: At inclusion and a month after CPAP initiation
Evolution of the somnolence
Epworth Sleepiness Score (ESS):
0 = no chance of dozing or falling asleep
- = low chance of falling asleep
- = medium chance of falling asleep
- = high chance of falling asleep
Measured: At inclusion and a month after CPAP initiation
Evolution of the quality of life by the Short Form 36 health survey questionnaire
A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: At inclusion and a month after CPAP initiation
Evolution of the compliance of CPAP treatment
Collection of average CPAP treatment use (in hours/day) provided by telemonitoring
Measured: For a month during CPAP treatment
Evolution of the effectiveness of CPAP treatment
Collection of residual AHI provided by telemonitoring
Measured: For a month during CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start3 Oct 2022
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Dreem, AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Jean Louis Pépin, MD, PhD, Principal investigator, Grenoble Alpes University Hospital (CHUGA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197855
- Sponsor's protocol ID
- 38RC21.0346
- Status last verified
- May 2026
- First submitted
- 1 Dec 2021
- Last updated
- 17 Jun 2026
- 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Sleep Quality During the Initiation of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome: An Exploratory Study
- ClinicalTrials.gov ID
- NCT05197855
- Acronym / sponsor ID
- 38RC21.0346
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea
- Keywords
- Continuous Positive Airway Pressure (CPAP), Technological innovations, Sleep Stages, Dreem Headband
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Dreem, AGIR à Dom
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 20 Jan 2022 (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.
Continuous positive airway pressure (CPAP) has a caricatural effect in reducing nocturnal respiratory abnormalities and improving the micro-and macrostructure of sleep. Studies characterizing the improvement of acute sleep parameters after the initiation of CPAP are limited to one or two nights of polysomnographic recording. This is related to the cost of performing these studies with repeated recordings in the laboratory and to the acceptability by patients to perform multiple nights of recordings.
Investigators currently have powerful and reliable methods allowing us to carry out nights at home in the patient's ecosystem, in real-life conditions. The characterization of sleep parameters by these methods is equivalent to a polysomnographic recording.
These technological innovations will allow us to characterize sleep before the initiation of CPAP treatment during several nights performed at home. Investigators will then be able to characterize the kinetics and stability of the improvement of sleep parameters in patients with obstructive sleep apnea syndrome in whom continuous positive airway pressure is initiated.
These data will be original and will serve as exploratory data to judge whether the objective improvement of sleep parameters in the first weeks of treatment is associated with improvement in sleepiness, quality of life, and compliance with treatment.
Detailed description
This study aims to evaluate the quality of sleep, principally the deep slow-wave sleep (sleep stage N3) before and after the initiation of continuous positive airway pressure (CPAP) treatment.
70 newly diagnosed patients with OSA requiring CPAP treatment, will be included.
For the study, they will wear the Dreem 3 headband and pulse oximeter at home before initiation of CPAP (for 7 nights) and during the first month of CPAP (for a minimum of 9 nights). They will be also equipped with a glucose sensor and a pedometer during the entire study period before and after CPAP treatment.
Patients will also complete questionnaires about their health status before CPAP treatment (at inclusion) and after one month of treatment
These devices will allow the measurements of different parameters: sleep stages, total sleep time, sleep measures derived from sleep stages, snoring, breathing rate, heart rate head movements, arterial hemoglobin oxygen saturation, pulse rate, continuous subcutaneous glucose level, and physical activity data (average daily steps, average distance walked per day).
This will generate interesting data on the sleep parameters and their evolution during the initiation of the CPAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Technological innovations and CPAP | Experimental | Device: Deem 3 HeadbandPatients will be equipped with 4 devices: a Dreem 3 Headband, a pulse oximeter, a continuous glucose sensor, and a pedometer. In parallel they will be equipped by the CPAP at home by Icadom. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients newly diagnosed with OSA requiring CPAP treatment
- Patients able to use a mobile application on a smartphone or tablet
- Patients with access to a wi-fi internet connection at home
- Patients agreeing to remote monitoring of CPAP compliance data by the home care provider
- Patients who have signed consent to participate in the study
Key exclusion criteria (7 listed)
- Patients already treated for OSA
- Patients treated with a sleep aid (sleeping medications)
- Patients with severe chronic obstructive or restrictive lung disease with or without oxygen
- Patients with unstable cardiovascular disease or severe heart failure requiring hospitalization within the last three months or meeting New York Heart Association criteria, Class III or IV disease
- Subjects listed in articles L1121-5 to L1121-8: pregnant women, feeding and parturients, subjects deprived of liberty by judicial or administrative decision, persons under legal protection
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 |
|---|---|---|
| Deem 3 HeadbandThe patient will wear the Dreem 3 headband and pulse oximeter at home before initiation of CPAP (for 7 nights) and during a month of treatment (for a minimum of 9 nights), after the initiation of CPAP. He will also wear a glucose sensor and a pedometer during the entire study period before and after CPAP treatment. | Device | Technological innovations and CPAP |
Primary outcome
Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment.
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Time spent on the deep slow-wave sleep stage (stage N3 sleep), recorded by the Dreem 3 headband, from 7 nights before and 9 nights after initiation of CPAP treatment
19 secondary outcomes
Duration of the other sleep stages (W, N1, N2 and REM)
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Duration of different sleep times
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The percentage of time while sleeping
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The frequences of sleep waves during the NREM sleep stage recorded by Dreem 3 headband
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The frequence of snoring while sleeping recorded by Dreem 3 headband
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Respiratory rate measurment recorded by Dreem 3 headband
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Heart rate measurement while sleepingrecorded by Dreem 3 headband
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
The position of the head changes while sleeping recorded by Dreem 3 headband
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Evolution of the nocturnal oximetry
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Evolution of the subcutaneous glucose level
Time frame: 7 nights before CPAP initiation and for a month after CPAP initiation
Evolution of glycemia
Time frame: At inclusion and a month after CPAP initiation
Average daily number of steps
Time frame: 7 nights before CPAP initiation and for a month after CPAP initiation
Average distance walked per day
Time frame: 7 nights before CPAP initiation and for a month after CPAP initiation
Sleep quality assessed by Pittsburg questionnaire
Time frame: At inclusion and a month after CPAP initiation
Severity of insomnia measured by the index sverety of insomnia questionnaire
Time frame: At inclusion and a month after CPAP initiation
Evolution of the somnolence
Time frame: At inclusion and a month after CPAP initiation
Evolution of the quality of life by the Short Form 36 health survey questionnaire
Time frame: At inclusion and a month after CPAP initiation
Evolution of the compliance of CPAP treatment
Time frame: For a month during CPAP treatment
Evolution of the effectiveness of CPAP treatment
Time frame: For a month during CPAP treatment
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 17 Jun 2026.
- 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.
Jean Louis Pépin, MD, PhD principal investigator
Grenoble Alpes University Hospital (CHUGA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deem 3 Headband in people with Sleep Apnea and Obstructive Sleep Apnea, run by University Hospital, Grenoble 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 7 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 17 Jun 2026. 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?
Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment. (time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation). 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 17 Jun 2026.