CHU Grenoble
Grenoble, France
NCT Number: NCT02721329
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Grenoble, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Automatic Continuous Positive Airway Pressure
Other names: Automatic Continuous Positive Airway Pressure, Auto CPAP, ICON+ Auto
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.
Other names: Automatic Continuous Positive Airway Pressure with SensAwake Pressure relief, ICON+ Auto with SensAwake Pressure relief, Auto CPAP with SensAwake Pressure relief
Time frame: Four weeks
Amount of time spent awake after sleep onset, as measured by actigraphy
Time frame: Four weeks
Total sleep time, as measured by actigraphy - nightly average
Time frame: Four weeks
Time it takes to fall asleep, as measured by actigraphy - nightly average
Time frame: Four weeks
Percentage of time in bed spent asleep, as measured by actigraphy - nightly average
Time frame: Four weeks
Time spent on CPAP treatment - nightly average
Time frame: Four weeks
Questionnaire
Time frame: Four weeks
Questionnaire
Time frame: Four weeks
Questionnaire
Time frame: Four weeks
Questionnaire
Time frame: 24 hours
Measured by 24 hour ambulatory blood pressure
Fisher and Paykel Healthcare
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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