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Evaluation of APAP With SensAwake in OSA and Insomnia Patients

Primary Purpose

Obstructive Sleep Apnea, Insomnia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
APAP
APAP with SensAwake
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, OSA, Insomnia, CPAP, SensAwake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

APAP without SensAwake

APAP with SensAwake

Arm Description

Auto CPAP delivered from the ICON+ CPAP device.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2016
Last Updated
June 30, 2020
Sponsor
Fisher and Paykel Healthcare
Collaborators
University Hospital, Grenoble, University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02721329
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
Collaborators
University Hospital, Grenoble, University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Insomnia
Keywords
Obstructive Sleep Apnea, OSA, Insomnia, CPAP, SensAwake

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APAP without SensAwake
Arm Type
Active Comparator
Arm Description
Auto CPAP delivered from the ICON+ CPAP device.
Arm Title
APAP with SensAwake
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
APAP
Other Intervention Name(s)
Automatic Continuous Positive Airway Pressure, Auto CPAP, ICON+ Auto
Intervention Description
Automatic Continuous Positive Airway Pressure
Intervention Type
Device
Intervention Name(s)
APAP with SensAwake
Other Intervention Name(s)
Automatic Continuous Positive Airway Pressure with SensAwake Pressure relief, ICON+ Auto with SensAwake Pressure relief, Auto CPAP with SensAwake Pressure relief
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Sleep Quality - Wake After Sleep Onset (WASO)
Description
Amount of time spent awake after sleep onset, as measured by actigraphy
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Objective Sleep Quality - Total Sleep Time
Description
Total sleep time, as measured by actigraphy - nightly average
Time Frame
Four weeks
Title
Objective Sleep Quality - Sleep Onset Latency
Description
Time it takes to fall asleep, as measured by actigraphy - nightly average
Time Frame
Four weeks
Title
Objective Sleep Quality - Sleep efficiency
Description
Percentage of time in bed spent asleep, as measured by actigraphy - nightly average
Time Frame
Four weeks
Title
Treatment compliance
Description
Time spent on CPAP treatment - nightly average
Time Frame
Four weeks
Title
Subjective sleep quality - Pittsburgh Sleep Quality Index
Description
Questionnaire
Time Frame
Four weeks
Title
Insomnia severity - Insomnia Severity Index
Description
Questionnaire
Time Frame
Four weeks
Title
Daytime sleepiness - Epworth Sleepiness Score
Description
Questionnaire
Time Frame
Four weeks
Title
Quality of Life - Short Form 12
Description
Questionnaire
Time Frame
Four weeks
Title
Blood pressure
Description
Measured by 24 hour ambulatory blood pressure
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Pepin, MD
Organizational Affiliation
CHU du Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of APAP With SensAwake in OSA and Insomnia Patients

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