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Comparison Study of the ICONâ„¢ Auto Series With and Without SensAwakeâ„¢ and ThermoSmartâ„¢ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients

NCT01517763 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-06-10

Study results available
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Summary

A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICONâ„¢ AT with SensAwakeâ„¢ and ThermoSmartâ„¢ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwakeâ„¢, ThermoSmartâ„¢) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

Conventional CPAP Therapy

HC244 devices without Thermosmart or SensAwake

DEVICE

Fixed pressure ICONâ„¢ without ThermoSmartâ„¢

Fixed pressure CPAP therapy using ICONâ„¢ without ThermoSmartâ„¢ or SensAwakeâ„¢

DEVICE

Auto ICONâ„¢ with SensAwakeâ„¢ and ThermoSmartâ„¢

APAP therapy using Auto ICONâ„¢ with SensAwakeâ„¢ and ThermoSmartâ„¢

Sponsors & Collaborators

  • Sleep Health Centers

    collaborator OTHER

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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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 NCT01517763 on ClinicalTrials.gov