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Completed

NCT Number: NCT01831258

Comparison Study of the ICON™ CPAP Series With and Without SensAwake™

Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.

The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology.

It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Associates, Glendale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
  • Successful in-lab titration polysomnography (PSG)
  • General (at home) sleep habits of:
  • At least 7 hours in bed on most nights
  • Lights out at 12 midnight or earlier
  • Fluency in both written and spoken English.

Exclusion criteria

  • Participants prescribed and fitted with any PAP device in the past 2 years
  • Contraindicated for CPAP or AutoCPAP therapy.
  • Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
  • Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
  • Patients who are prescribed hypnotics and sedating medications.
  • Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.
  • If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
  • If the physician objects to their patient taking part in the study.

Treatment and study plan

SensAwake On

Device

SensAwake Off

Device

Primary outcomes

  1. Adherence to CPAP Treatment

    Time frame: 2 weeks

    Average used minutes (all days) taken from the CPAP device.

Secondary outcomes

  1. Daytime Sleepiness (Subjective Sleep Quality)

    Time frame: 4 weeks

    Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.

  2. Insomnia Severity Index (Subjective Sleep Quality)

    Time frame: 4 weeks

    Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).

  3. OSA Impact of Daily Life

    Time frame: 4 weeks

    Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.

  4. OSA Impact of Daily Life (Fatigue)

    Time frame: 4 weeks

    Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.

  5. Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity

    Time frame: 4 weeks

    Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.

  6. Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change

    Time frame: 4 weeks

    Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.

Other outcomes

  1. Leak

    Time frame: One night

    The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device

  2. Apnea Hypopnea Index (AHI)

    Time frame: 2 weeks

    Collected through the device

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 15, 2013
Registry last updated
Jul 19, 2017

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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