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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02971436

Enrollment

Registered

2016-11-23

Start date

2016-12-31

Completion date

2017-08-31

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief 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.

Interventions

DEVICEFPH Device with SensAwake On + Pressure Support A

FPH Device with SensAwake On + Pressure Support A

DEVICEFPH Device with SensAwake Off + Pressure Support A

FPH Device with SensAwake Off + Pressure Support A

DEVICEFPH Device with SensAwake On + Pressure Support B

FPH Device with SensAwake On + Pressure Support B

DEVICEFPH Device with SensAwake Off + Pressure Support B

FPH Device with SensAwake Off + Pressure Support B

DEVICECompetitor's PAP Released Device + Pressure Support A

Competitor's PAP Released Device + Pressure Support A

DEVICECompetitor's PAP Released Device + Pressure Support B

Competitor's PAP Released Device + Pressure Support B

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Apnea Hypopnea Index (AHI)	3 nights	Through the device and independent flow logger

Secondary

Measure	Time frame	Description
Therapy Comfort	3 nights	Through a subjective questionnaire
Compliance	3 nights	Through the device and independent flow logger
Device Triggering	3 nights	Through the device

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026