Status:
COMPLETED
ThErapy Adherence Management in Veterans
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Philips Respironics
US Department of Veterans Affairs
Conditions:
Obstructive Sleep Apnea of Adult
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
The study is a prospective, randomized, controlled trial studying adherence to positive airway pressure therapy in a population referred to the VA system for the treatment of sleep disordered breathin...
Detailed Description
The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information progra...
Eligibility Criteria
Inclusion
- Ages 21 to 85
- Diagnostic Apnoea-Hypopnoea Index (AHI) ≥ 15 determined by in lab polysomnography (PSG) or home sleep testing (HST) or by a sleep therapy device
- Eligible for treatment with Automatically adjusted CPAP or Automatically adjusted BiPAP
- Currently has a Smart Phone or home access (computer with internet access) to the internet based version of the software application
Exclusion
- Participation in another interventional research concerned with sleep disorders within the last 30 days
- Major uncontrolled medical condition that would interfere with the demands of the study, adherence to PAP, or the ability to commit to follow-up assessment including conditions such as poorly managed or controlled or advanced stages of pulmonary disease, cardiac disease, neurological disease, neuromuscular disease, cancer, and renal disease.
- Prior PAP use within the previous 12 months.
- Predominantly Central Apneas (≥ 50% central apneas) or Cheyne Stokes Respiration (CSR) (≥ 20% of Total Sleep Time (TST) with CSR)
- Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake or the requirement for supplemental oxygen (at night or continuous) or mechanical ventilation.
- Surgery involving the upper airway, nose, sinus, eye, teeth, or middle ear within the previous 90 days
- PAP therapy is otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks
Key Trial Info
Start Date :
August 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2019
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03243487
Start Date
August 8 2017
End Date
May 9 2019
Last Update
May 13 2019
Active Locations (2)
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1
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608
2
University of Florida
Gainesville, Florida, United States, 32611