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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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FPH Device with SensAwake On + Pressure Support A

Group Type ACTIVE_COMPARATOR

FPH Device with SensAwake On + Pressure Support A

Intervention Type DEVICE

FPH Device with SensAwake On + Pressure Support A

FPH Device with SensAwake Off + Pressure Support A

Group Type ACTIVE_COMPARATOR

FPH Device with SensAwake Off + Pressure Support A

Intervention Type DEVICE

FPH Device with SensAwake Off + Pressure Support A

FPH Device with SensAwake On + Pressure Support B

Group Type ACTIVE_COMPARATOR

FPH Device with SensAwake On + Pressure Support B

Intervention Type DEVICE

FPH Device with SensAwake On + Pressure Support B

FPH Device with SensAwake Off + Pressure Support B

Group Type ACTIVE_COMPARATOR

FPH Device with SensAwake Off + Pressure Support B

Intervention Type DEVICE

FPH Device with SensAwake Off + Pressure Support B

Competitor's PAP Released Device + Pressure Support A

Group Type ACTIVE_COMPARATOR

Competitor's PAP Released Device + Pressure Support A

Intervention Type DEVICE

Competitor's PAP Released Device + Pressure Support A

Competitor's PAP Released Device + Pressure Support B

Group Type ACTIVE_COMPARATOR

Competitor's PAP Released Device + Pressure Support B

Intervention Type DEVICE

Competitor's PAP Released Device + Pressure Support B

Interventions

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FPH Device with SensAwake On + Pressure Support A

Intervention Type DEVICE

FPH Device with SensAwake Off + Pressure Support A

Intervention Type DEVICE

FPH Device with SensAwake On + Pressure Support B

Intervention Type DEVICE

FPH Device with SensAwake Off + Pressure Support B

Intervention Type DEVICE

Competitor's PAP Released Device + Pressure Support A

Intervention Type DEVICE

Competitor's PAP Released Device + Pressure Support B

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No