Evaluation of APAP With SensAwake in OSA and Insomnia Patients

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Insomnia
• Interventions: Device: APAP; Device: APAP with SensAwake

• Registration Number: NCT02721329
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-03-29
• Study Start: 2016-06
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
APAP without SensAwake	APAP	Auto CPAP delivered from the ICON+ CPAP device.
APAP with SensAwake	APAP with SensAwake	Auto CPAP with SensAwake turned on and set at a pressure of 4cmH2O. SensAwake is a pressure relief function that reduces the CPAP pressure on the transition from sleep to wake.

Primary Outcome Measures

Name	Time	Method
Objective Sleep Quality - Wake After Sleep Onset (WASO)	Four weeks	Amount of time spent awake after sleep onset, as measured by actigraphy

Secondary Outcome Measures

Name	Time	Method
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
Insomnia severity - Insomnia Severity Index	Four weeks	Questionnaire
Blood pressure	24 hours	Measured by 24 hour ambulatory blood pressure
Daytime sleepiness - Epworth Sleepiness Score	Four weeks	Questionnaire
Objective Sleep Quality - Total Sleep Time	Four weeks	Total sleep time, as measured by actigraphy - nightly average
Objective Sleep Quality - Sleep Onset Latency	Four weeks	Time it takes to fall asleep, as measured by actigraphy - nightly average
Subjective sleep quality - Pittsburgh Sleep Quality Index	Four weeks	Questionnaire
Quality of Life - Short Form 12	Four weeks	Questionnaire

Trial Locations

Locations (1)

CHU Grenoble; 🇫🇷 Grenoble, France