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Evaluation of APAP With SensAwake in OSA and Insomnia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721329
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
University Hospital, Grenoble
University Hospital, Angers
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Insomnia Device: APAP Device: APAP with SensAwake Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of APAP With SensAwake in OSA and Insomnia Patients
Study Start Date : June 2016
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Objective Sleep Quality - Wake After Sleep Onset (WASO) [ Time Frame: Four weeks ]
    Amount of time spent awake after sleep onset, as measured by actigraphy


Secondary Outcome Measures :
  1. Objective Sleep Quality - Total Sleep Time [ Time Frame: Four weeks ]
    Total sleep time, as measured by actigraphy - nightly average

  2. Objective Sleep Quality - Sleep Onset Latency [ Time Frame: Four weeks ]
    Time it takes to fall asleep, as measured by actigraphy - nightly average

  3. Objective Sleep Quality - Sleep efficiency [ Time Frame: Four weeks ]
    Percentage of time in bed spent asleep, as measured by actigraphy - nightly average

  4. Treatment compliance [ Time Frame: Four weeks ]
    Time spent on CPAP treatment - nightly average

  5. Subjective sleep quality - Pittsburgh Sleep Quality Index [ Time Frame: Four weeks ]
    Questionnaire

  6. Insomnia severity - Insomnia Severity Index [ Time Frame: Four weeks ]
    Questionnaire

  7. Daytime sleepiness - Epworth Sleepiness Score [ Time Frame: Four weeks ]
    Questionnaire

  8. Quality of Life - Short Form 12 [ Time Frame: Four weeks ]
    Questionnaire

  9. Blood pressure [ Time Frame: 24 hours ]
    Measured by 24 hour ambulatory blood pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721329


Locations
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France
CHU Grenoble
Grenoble, France
Sponsors and Collaborators
Fisher and Paykel Healthcare
University Hospital, Grenoble
University Hospital, Angers
Investigators
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Principal Investigator: Jean-Louis Pepin, MD CHU du Grenoble
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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02721329    
Other Study ID Numbers: CIA-151
2015-000407-57 ( EudraCT Number )
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fisher and Paykel Healthcare:
Obstructive Sleep Apnea
OSA
Insomnia
CPAP
SensAwake
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Initiation and Maintenance Disorders
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics