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

Sleep Apnea, Obstructive Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01517763
• Other study ID #: FPH-SA09-01
• Status: Terminated
• Phase: N/A
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2019
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Conventional CPAP Therapy
HC244 devices without Thermosmart or SensAwake
• Fixed pressure ICON™ without ThermoSmart™
Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™
• Auto ICON™ with SensAwake™ and ThermoSmart™
APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™

Locations

Country	Name	City	State
United States	Sleep HealthCenters	Brighton	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare	Sleep Health Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.		On day 90 after randomization
Secondary	Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.		On day 90 after randomization