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

This study has been terminated.
(The site closed down, therefore the study has been terminated.)
Sponsor:
Collaborator:
Sleep Health Centers
Information provided by (Responsible Party):
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT01517763
First received: January 17, 2012
Last updated: September 28, 2014
Last verified: September 2014

January 17, 2012
September 28, 2014
January 2012
September 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01517763 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
Not Provided

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Sleep Apnea, Obstructive
  • Device: Conventional CPAP Therapy
    HC244 devices without Thermosmart or SensAwake
  • Device: Fixed pressure ICON™ without ThermoSmart™
    Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™
  • Device: Auto ICON™ with SensAwake™ and ThermoSmart™
    APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™
  • Placebo Comparator: Conventional CPAP
    Fisher & Paykel HC244™
    Intervention: Device: Conventional CPAP Therapy
  • Active Comparator: CPAP without Humidification
    Fixed pressure ICON™ without ThermoSmart™
    Intervention: Device: Fixed pressure ICON™ without ThermoSmart™
  • Experimental: APAP with all technologies
    Auto ICON™ with SensAwake™ and ThermoSmart™
    Intervention: Device: Auto ICON™ with SensAwake™ and ThermoSmart™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517763
FPH-SA09-01
No
Fisher and Paykel Healthcare
Fisher and Paykel Healthcare
Sleep Health Centers
Not Provided
Fisher and Paykel Healthcare
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP