Obstructive Sleep Apnea of Adult
Conditions
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 breathing. 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 program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting Centers for Medicare & Medicaid Services (CMS) adherence requirements (use \> 4 hours for \>= 70% of days) at 90 days.
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 program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting CMS adherence requirements (use \> 4hrs on \>=70% of nights) at 90 days. Secondary aims: 1. Results in higher nightly use of therapy (hours per night and % of nights with at least 4 hours of use) at 90 days 2. Results in participant satisfaction that is superior to current standard care 3. Offers operational efficiencies or economic benefits to the health care facility (reduced staff time (sleep clinic and physician), equipment consumption, unplanned participant contacts or visits, and reduced overtime) 4. Results in indirect benefits to participants (fewer clinic visits, less travel or in-clinic/ office visit waiting time)
Interventions
BEHAVIORALstructured adherence management program
Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy
BEHAVIORALStandard of care
Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy
Sponsors
Philips Respironics
US Department of Veterans Affairs
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Study participants and study staff cannot be blinded to the treatment arm to which they are randomized. Data analysis will be blinded and conducted without revealing the treatment group assignment.
Intervention model description
After undergoing screening and enrollment, participants will be assigned to either standard care follow-up or to the patient adherence monitoring service (PAMS).
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase on CMS adherence requirements | at 90 days | The requirements are greater than 4 hours use for 70% of nights |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nightly use of therapy | at 90 days | Hours per night and % of nights with at least 4 hours of use |
| Participant satisfaction | at 90 days | Participants will complete at Patients Satisfaction Survey containing 5 questions about their satisfaction with CPAP treatment and the process of starting CPAP. There is a 5 point scale from very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very unsatisfied (5). Score can vary from 5 to 25. 30, |
| Operational efficiencies and economic benefits to the health care facility | at 90 days | Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time |
Countries
United States
Outcome results
None listed