Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
Status
Terminated
Conditions
Obstructive Sleep Apnea
Treatments
Device: FPH Device with SensAwake On + Pressure Support A
Device: FPH Device with SensAwake Off + Pressure Support B
Device: FPH Device with SensAwake Off + Pressure Support A
Device: Competitor's PAP Released Device + Pressure Support B
Device: Competitor's PAP Released Device + Pressure Support A
Device: FPH Device with SensAwake On + Pressure Support B
Details and patient eligibility
About
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.
Enrollment
29 patients
Sex
All
Ages
18+ years old
Volunteers
No 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Single Blind
29 participants in 6 patient groups
FPH Device with SensAwake On + Pressure Support A
Active Comparator group
Description:
FPH Device with SensAwake On + Pressure Support A
Treatment:
Device: FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A
Active Comparator group
Description:
FPH Device with SensAwake Off + Pressure Support A
Treatment:
Device: FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake On + Pressure Support B
Active Comparator group
Description:
FPH Device with SensAwake On + Pressure Support B
Treatment:
Device: FPH Device with SensAwake On + Pressure Support B
FPH Device with SensAwake Off + Pressure Support B
Active Comparator group
Description:
FPH Device with SensAwake Off + Pressure Support B
Treatment:
Device: FPH Device with SensAwake Off + Pressure Support B
Competitor's PAP Released Device + Pressure Support A
Active Comparator group
Description:
Competitor's PAP Released Device + Pressure Support A
Treatment:
Device: Competitor's PAP Released Device + Pressure Support A
Competitor's PAP Released Device + Pressure Support B
Active Comparator group
Description:
Competitor's PAP Released Device + Pressure Support B
Treatment:
Device: Competitor's PAP Released Device + Pressure Support B
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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