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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Grenoble Alpes University Hospital
Grenoble, France
RECRUITINGDuration 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
Time frame: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
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
Time frame: 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)
Time frame: 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)
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
sleep spindle density expressed in Hertz recorded by the EEG sensors
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
snoring is expressed in decibel minute recorded by a microphone integrated in the Dreem3
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
It is expressed in breathe per minute recorded accelerometer sensor
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
Expressed in beats per minute recorded by accelerometer sensor
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
Head movements are recorded by an accelerometer sensor in the 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
Nocturnal oxygen saturation measured by a pulse oximeter
Time frame: 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)
Time frame: 7 nights before CPAP initiation and for a month after CPAP initiation
Evolution of glycemia
Blood glucose level by blood sampling
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: At inclusion and a month after CPAP initiation
Evolution of the somnolence
Epworth Sleepiness Score (ESS): 0 = no chance of dozing or falling asleep 1. = low chance of falling asleep 2. = medium chance of falling asleep 3. = high chance of falling asleep
Time frame: 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.
Time frame: 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
Time frame: For a month during CPAP treatment
Evolution of the effectiveness of CPAP treatment
Collection of residual AHI provided by telemonitoring
Time frame: For a month during CPAP treatment
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