Study Stopped
project progression decision was able to be made with the data already gathered
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
1 other identifier
interventional
29
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedAugust 2, 2018
August 1, 2018
9 months
November 17, 2016
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Apnea Hypopnea Index (AHI)
Through the device and independent flow logger
3 nights
Apnea Hypopnea Index (AHI)
Through the polysomnography
1 night
Secondary Outcomes (4)
Therapy Comfort
3 nights
Compliance
3 nights
Device Triggering
3 nights
Device Triggering
1 night
Study Arms (6)
FPH Device with SensAwake On + Pressure Support A
ACTIVE COMPARATORFPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A
ACTIVE COMPARATORFPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake On + Pressure Support B
ACTIVE COMPARATORFPH Device with SensAwake On + Pressure Support B
FPH Device with SensAwake Off + Pressure Support B
ACTIVE COMPARATORFPH Device with SensAwake Off + Pressure Support B
Competitor's PAP Released Device + Pressure Support A
ACTIVE COMPARATORCompetitor's PAP Released Device + Pressure Support A
Competitor's PAP Released Device + Pressure Support B
ACTIVE COMPARATORCompetitor's PAP Released Device + Pressure Support B
Interventions
FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake On + 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 B
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fisher & Paykel Healthcare
Auckland, 0600, New Zealand
WellSleep Centre
Wellington, 6035, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 23, 2016
Study Start
December 1, 2016
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
August 2, 2018
Record last verified: 2018-08