Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517763
Recruitment Status : Terminated (The site closed down, therefore the study has been terminated.)
First Posted : January 25, 2012
Last Update Posted : September 30, 2014
Sleep Health Centers
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ 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, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Conventional CPAP Therapy Device: Fixed pressure ICON™ without ThermoSmart™ Device: Auto ICON™ with SensAwake™ and ThermoSmart™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Placebo Comparator: Conventional CPAP
Fisher & Paykel HC244™
Device: Conventional CPAP Therapy
HC244 devices without Thermosmart or SensAwake

Active Comparator: CPAP without Humidification
Fixed pressure ICON™ without ThermoSmart™
Device: Fixed pressure ICON™ without ThermoSmart™
Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™

Experimental: APAP with all technologies
Auto ICON™ with SensAwake™ and ThermoSmart™
Device: Auto ICON™ with SensAwake™ and ThermoSmart™
APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™

Primary Outcome Measures :
  1. Adherence with treatment per night averaged over total time period measured via internal software on the device and reported on using InfoSmart™ software. [ Time Frame: On day 90 after randomization ]

Secondary Outcome Measures :
  1. Adherence (hours of usage per night) and acceptance (number of drop-outs). Complaints during follow up calls and visit. [ Time Frame: On day 90 after randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
  • Successful titration Polysomnography (PSG).
  • 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.
  • Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
  • If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517763

United States, Massachusetts
Sleep HealthCenters
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
Fisher and Paykel Healthcare
Sleep Health Centers

Responsible Party: Fisher and Paykel Healthcare Identifier: NCT01517763     History of Changes
Other Study ID Numbers: FPH-SA09-01
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014

Keywords provided by Fisher and Paykel Healthcare:
Obstructive Sleep Apnea
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Immunologic Factors
Physiological Effects of Drugs