NCT01517763

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
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™

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-01-25
• Last updated: 2019-06-10
• Results posted: 2019-06-10

Locations

1 site across 1 country: United States