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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: SensAwake On; Device: SensAwake Off

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates
  • Georgia
    • Macon, Georgia, United States
      • SleepMed of Central Georgia
  • South Carolina
    • Columbia, South Carolina, United States
      • Sleep Med of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SensAwake On; The comfort feature 'SensAwake' will be turned on	Device: SensAwake On
Active Comparator: SensAwake Off; The comfort feature 'SensAwake' will be turned off	Device: SensAwake Off

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to CPAP Treatment	Average used minutes (all days) taken from the CPAP device.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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).	4 weeks
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.	4 weeks
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.	4 weeks
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.	4 weeks
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.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak	The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device	One night
Apnea Hypopnea Index (AHI)	Collected through the device	2 weeks

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: FPH-SA13-01