MedTrace Logo

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

NCT01831258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-07-19

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DEVICE

SensAwake On

DEVICE

SensAwake Off

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01831258 on ClinicalTrials.gov