NCT02971436

Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	FPH Device with SensAwake On + Pressure Support A	FPH Device with SensAwake On + Pressure Support A
DEVICE	FPH Device with SensAwake Off + Pressure Support A	FPH Device with SensAwake Off + Pressure Support A
DEVICE	FPH Device with SensAwake On + Pressure Support B	FPH Device with SensAwake On + Pressure Support B
DEVICE	FPH Device with SensAwake Off + Pressure Support B	FPH Device with SensAwake Off + Pressure Support B
DEVICE	Competitor's PAP Released Device + Pressure Support A	Competitor's PAP Released Device + Pressure Support A
DEVICE	Competitor's PAP Released Device + Pressure Support B	Competitor's PAP Released Device + Pressure Support B

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2016-11-23
• Last updated: 2018-08-02

Locations

2 sites across 1 country: New Zealand