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Completed

NCT Number: NCT02721329

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APAP

Device

Automatic Continuous Positive Airway Pressure

Other names: Automatic Continuous Positive Airway Pressure, Auto CPAP, ICON+ Auto

APAP with SensAwake

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Collaborators

  • University Hospital, Angers
  • University Hospital, Grenoble

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2016
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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