Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2022-10-03
2025-12-03
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Technological innovations and CPAP
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.
Deem 3 Headband
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.
Interventions
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Deem 3 Headband
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
65 Years
ALL
No
Sponsors
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Dreem
INDUSTRY
AGIR à Dom
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean Louis Pépin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Grenoble Alpes University Hospital (CHUGA)
Locations
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Grenoble Alpes University Hospital
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Jean Louis Pépin, MD, PhD
Role: primary
Marie Joyeux-Faure, PharmD, PhD
Role: backup
Jean Louis Pépin, MD, PhD
Role: backup
Renaud Tamisier, MD,PhD
Role: backup
Rita CHERPEC épouse CLIN, MD,PhD
Role: backup
Marie DESTORS, MD
Role: backup
Other Identifiers
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38RC21.0346
Identifier Type: -
Identifier Source: org_study_id