Evaluation of APAP With SensAwake in OSA and Insomnia Patients

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Obstructive Sleep Apnea
• Intervention / Treatment: Device: APAP; Device: APAP with SensAwake

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • CHU Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: APAP without SensAwake; Auto CPAP delivered from the ICON+ CPAP device.	Device: APAP; Automatic Continuous Positive Airway Pressure; Other Names: Automatic Continuous Positive Airway Pressure; Auto CPAP; ICON+ Auto
Experimental: 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.	Device: APAP 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.; Other Names: Automatic Continuous Positive Airway Pressure with SensAwake Pressure relief; ICON+ Auto with SensAwake Pressure relief; Auto CPAP with SensAwake Pressure relief

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Sleep Quality - Total Sleep Time	Total sleep time, as measured by actigraphy - nightly average	Four weeks
Objective Sleep Quality - Sleep Onset Latency	Time it takes to fall asleep, as measured by actigraphy - nightly average	Four weeks
Objective Sleep Quality - Sleep efficiency	Percentage of time in bed spent asleep, as measured by actigraphy - nightly average	Four weeks
Treatment compliance	Time spent on CPAP treatment - nightly average	Four weeks
Subjective sleep quality - Pittsburgh Sleep Quality Index	Questionnaire	Four weeks
Insomnia severity - Insomnia Severity Index	Questionnaire	Four weeks
Daytime sleepiness - Epworth Sleepiness Score	Questionnaire	Four weeks
Quality of Life - Short Form 12	Questionnaire	Four weeks
Blood pressure	Measured by 24 hour ambulatory blood pressure	24 hours

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Collaborators: University Hospital, Angers; University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Louis Pepin, MD, CHU du Grenoble

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: OSA; Obstructive Sleep Apnea; Insomnia; CPAP; SensAwake
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: CIA-151; 2015-000407-57 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No