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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SensAwake On
SensAwake Off
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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pulmonary Associates
  • SleepMed of Central Georgia
  • Sleep Med of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SensAwake On

SensAwake Off

Arm Description

The comfort feature 'SensAwake' will be turned on

The comfort feature 'SensAwake' will be turned off

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Daytime Sleepiness (Subjective Sleep Quality)
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.
Insomnia Severity Index (Subjective Sleep Quality)
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).
OSA Impact of Daily Life
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.
OSA Impact of Daily Life (Fatigue)
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.
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity
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.
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change
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.

Full Information

First Posted
April 2, 2013
Last Updated
June 20, 2017
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01831258
Brief Title
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SensAwake On
Arm Type
Experimental
Arm Description
The comfort feature 'SensAwake' will be turned on
Arm Title
SensAwake Off
Arm Type
Active Comparator
Arm Description
The comfort feature 'SensAwake' will be turned off
Intervention Type
Device
Intervention Name(s)
SensAwake On
Intervention Type
Device
Intervention Name(s)
SensAwake Off
Primary Outcome Measure Information:
Title
Adherence to CPAP Treatment
Description
Average used minutes (all days) taken from the CPAP device.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Daytime Sleepiness (Subjective Sleep Quality)
Description
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.
Time Frame
4 weeks
Title
Insomnia Severity Index (Subjective Sleep Quality)
Description
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).
Time Frame
4 weeks
Title
OSA Impact of Daily Life
Description
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.
Time Frame
4 weeks
Title
OSA Impact of Daily Life (Fatigue)
Description
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.
Time Frame
4 weeks
Title
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity
Description
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.
Time Frame
4 weeks
Title
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Leak
Description
The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device
Time Frame
One night
Title
Apnea Hypopnea Index (AHI)
Description
Collected through the device
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pulmonary Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
SleepMed of Central Georgia
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Sleep Med of South Carolina
City
Columbia
State/Province
South Carolina
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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