Clinical trial NCT02721329: Evaluation of APAP With SensAwake in OSA and Insomnia Patients
Official title: Evaluation of APAP With SensAwake in OSA and Insomnia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Insomnia
Keywords: Obstructive Sleep Apnea
OSA
Insomnia
CPAP
SensAwake
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Grenoble
name: University Hospital, Angers
First posted: 2016-03-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Sleep Quality - Wake After Sleep Onset (WASO)
timeFrame: Four weeks
Secondary outcomes:
measure: Objective Sleep Quality - Total Sleep Time
timeFrame: Four weeks
measure: Objective Sleep Quality - Sleep Onset Latency
timeFrame: Four weeks
measure: Objective Sleep Quality - Sleep efficiency
timeFrame: Four weeks
measure: Treatment compliance
timeFrame: Four weeks
measure: Subjective sleep quality - Pittsburgh Sleep Quality Index
timeFrame: Four weeks
measure: Insomnia severity - Insomnia Severity Index
timeFrame: Four weeks
measure: Daytime sleepiness - Epworth Sleepiness Score
timeFrame: Four weeks
measure: Quality of Life - Short Form 12
timeFrame: Four weeks
measure: Blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: CHU du Grenoble
name: Jean-Louis Pepin, MD
role: PRINCIPAL_INVESTIGATOR
References: