Insomnia, Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, OSA, Insomnia, CPAP, SensAwake
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAPAP
Automatic Continuous Positive Airway Pressure
DEVICEAPAP with SensAwake
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.
Sponsors
University Hospital, Grenoble
University Hospital, Angers
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years of age. * Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI\>30 with no more than 20% of central respiratory events) * Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years. * Fluent in spoken and written French
Exclusion criteria
* Significant uncontrolled cardiac disease, as per the principal investigator's discretion, and/or Left Ventricular Ejection Fraction (LVEF) \< 45% * Co-existing lung disease, as per the principal investigator's discretion * Co-existing sleep disorder, such as predominant central sleep apnea * Previous or current diagnosis of sleep phase delay * Pregnancy * Participants that are unable or unwilling to give informed consent * Receiving cognitive behavioral therapy or other intervention to treat insomnia. Subjects may be using hypnotics, but there shall be no change in hypnotic use during the protocol or 4 weeks preceding enrolment into the study. * Diagnosed with clinical depression and/or currently using anti-depressants and/or anti-anxiolytics within the last 6 months. * Hospital Anxiety OR Depression score \> 11 * Participating in another research study for the duration of participation in this study. Participation in an observational study or genetic study is permitted at the discretion of the investigator. * Patient protected by the Law, under guardianship or curators, as defined in Public Health Code in articles from L1121-5 to L1121-8. * Patient not covered by a health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Sleep Quality - Wake After Sleep Onset (WASO) | Four weeks | Amount of time spent awake after sleep onset, as measured by actigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Sleep Quality - Sleep Onset Latency | Four weeks | Time it takes to fall asleep, as measured by actigraphy - nightly average |
| Objective Sleep Quality - Sleep efficiency | Four weeks | Percentage of time in bed spent asleep, as measured by actigraphy - nightly average |
| Treatment compliance | Four weeks | Time spent on CPAP treatment - nightly average |
| Subjective sleep quality - Pittsburgh Sleep Quality Index | Four weeks | Questionnaire |
| Objective Sleep Quality - Total Sleep Time | Four weeks | Total sleep time, as measured by actigraphy - nightly average |
| Daytime sleepiness - Epworth Sleepiness Score | Four weeks | Questionnaire |
| Quality of Life - Short Form 12 | Four weeks | Questionnaire |
| Blood pressure | 24 hours | Measured by 24 hour ambulatory blood pressure |
| Insomnia severity - Insomnia Severity Index | Four weeks | Questionnaire |
Countries
France
Outcome results
None listed