The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.
Patients with OSA and Insomnia will be enrolled into this randomized study to receive treatment with APAP with and without SensAwake. Baseline data will be collected for one week prior to CPAP initiation, followed by two treatment periods on each study arm of four weeks each.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
Automatic Continuous Positive Airway Pressure
Automatic Continuous Positive Airway Pressure with SensAwake enabled. SensAwake is a pressure relief technology that detects the transition from sleep to wake, and promptly reduces the pressure during wakeful periods.
CHU Grenoble
Grenoble, France
Objective Sleep Quality - Wake After Sleep Onset (WASO)
Amount of time spent awake after sleep onset, as measured by actigraphy
Time frame: Four weeks
Objective Sleep Quality - Total Sleep Time
Total sleep time, as measured by actigraphy - nightly average
Time frame: Four weeks
Objective Sleep Quality - Sleep Onset Latency
Time it takes to fall asleep, as measured by actigraphy - nightly average
Time frame: Four weeks
Objective Sleep Quality - Sleep efficiency
Percentage of time in bed spent asleep, as measured by actigraphy - nightly average
Time frame: Four weeks
Treatment compliance
Time spent on CPAP treatment - nightly average
Time frame: Four weeks
Subjective sleep quality - Pittsburgh Sleep Quality Index
Questionnaire
Time frame: Four weeks
Insomnia severity - Insomnia Severity Index
Questionnaire
Time frame: Four weeks
Daytime sleepiness - Epworth Sleepiness Score
Questionnaire
Time frame: Four weeks
Quality of Life - Short Form 12
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Questionnaire
Time frame: Four weeks
Blood pressure
Measured by 24 hour ambulatory blood pressure
Time frame: 24 hours