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 suspended participant recruitment.
(The site closed down, therefore the study is suspended until further notice)
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 12, 2013
Last verified: September 2013
  Purpose

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 Intervention
Sleep Apnea, Obstructive
Device: Conventional CPAP Therapy
Device: Fixed pressure ICON™ without ThermoSmart™
Device: Auto ICON™ with SensAwake™ and ThermoSmart™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 216
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517763

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

No publications provided

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01517763     History of Changes
Other Study ID Numbers: FPH-SA09-01
Study First Received: January 17, 2012
Last Updated: September 12, 2013
Health Authority: New Zealand: Food Safety Authority

Keywords provided by Fisher and Paykel Healthcare:
Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure
ICON
ThermoSmart
SensAwake

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014