Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

SensAwake On

+ SensAwake Off

Device
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

From 18 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorFisher and Paykel Healthcare
Last updated: July 19, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01831258
Principal SponsorFisher and Paykel Healthcare
Last updated: July 19, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea, Obstructive

Criteria

6 inclusion criteria required to participate
Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour)
At least 7 hours in bed on most nights
Fluency in both written and spoken English
General (at home) sleep habits of
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8 exclusion criteria prevent from participating
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
Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months
Contraindicated for CPAP or AutoCPAP therapy
If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The comfort feature 'SensAwake' will be turned on

Group II

Active Comparator
The comfort feature 'SensAwake' will be turned off

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Pulmonary Associates

Glendale, United StatesOpen Pulmonary Associates in Google Maps

SleepMed of Central Georgia

Macon, United States

Sleep Med of South Carolina

Columbia, United States
Completed3 Study Centers