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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02971436
• Other study ID #: CIA196
• Status: Terminated
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: August 2018
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 and over

• Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.

• For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)

Exclusion Criteria:

• Contraindicated for PAP (CPAP or AutoCPAP) therapy

• Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)

• Persons with obesity hypoventilation syndrome or congestive heart failure.

• Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device

• Persons with implanted electronic medical device (e.g cardiac pacemakers)

• Persons who are pregnant or think they might be pregnant.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake On + Pressure Support A
• FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A
• FPH Device with SensAwake On + Pressure Support B
FPH Device with SensAwake On + Pressure Support B
• FPH Device with SensAwake Off + Pressure Support B
FPH Device with SensAwake Off + Pressure Support B
• Competitor's PAP Released Device + Pressure Support A
Competitor's PAP Released Device + Pressure Support A
• Competitor's PAP Released Device + Pressure Support B
Competitor's PAP Released Device + Pressure Support B

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare	Auckland
New Zealand	WellSleep Centre	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI)	Through the device and independent flow logger	3 nights
Primary	Apnea Hypopnea Index (AHI)	Through the polysomnography	1 night
Secondary	Therapy Comfort	Through a subjective questionnaire	3 nights
Secondary	Compliance	Through the device and independent flow logger	3 nights
Secondary	Device Triggering	Through the device	3 nights
Secondary	Device Triggering	Through the polysomnography	1 night