Clinical trial NCT05197855: Sleep Quality Evolution: Dreem Under CPAP
Official title: Evolution of Sleep Quality During the Initiation of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Obstructive Sleep Apnea
Keywords: Continuous Positive Airway Pressure (CPAP)
Technological innovations
Sleep Stages
Dreem Headband
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Dreem
name: AGIR à Dom
First posted: 2022-01-20
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment.
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Secondary outcomes:
measure: Duration of the other sleep stages (W, N1, N2 and REM)
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: Duration of different sleep times
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: The percentage of time while sleeping
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: The frequences of sleep waves during the NREM sleep stage recorded by Dreem 3 headband
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: The frequence of snoring while sleeping recorded by Dreem 3 headband
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: Respiratory rate measurment recorded by Dreem 3 headband
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: Heart rate measurement while sleepingrecorded by Dreem 3 headband
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: The position of the head changes while sleeping recorded by Dreem 3 headband
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: Evolution of the nocturnal oximetry
timeFrame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
measure: Evolution of the subcutaneous glucose level
timeFrame: 7 nights before CPAP initiation and for a month after CPAP initiation
measure: Evolution of glycemia
timeFrame: At inclusion and a month after CPAP initiation
measure: Average daily number of steps
timeFrame: 7 nights before CPAP initiation and for a month after CPAP initiation
measure: Average distance walked per day
timeFrame: 7 nights before CPAP initiation and for a month after CPAP initiation
measure: Sleep quality assessed by Pittsburg questionnaire
timeFrame: At inclusion and a month after CPAP initiation
measure: Severity of insomnia measured by the index sverety of insomnia questionnaire
timeFrame: At inclusion and a month after CPAP initiation
measure: Evolution of the somnolence
timeFrame: At inclusion and a month after CPAP initiation
measure: Evolution of the quality of life by the Short Form 36 health survey questionnaire
timeFrame: At inclusion and a month after CPAP initiation
measure: Evolution of the compliance of CPAP treatment
timeFrame: For a month during CPAP treatment
measure: Evolution of the effectiveness of CPAP treatment
timeFrame: For a month during CPAP treatment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
Study officials:
affiliation: Grenoble Alpes University Hospital (CHUGA)
name: Jean Louis Pépin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: