Promoting Continuous Positive Airway Pressure (CPAP) Adherence

Completed · Early Phase 1

Conditions studied: Obstructive Sleep Apnea

In brief

The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3 groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least 4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and quality of life will evaluate whether patients provided web-based access to their daily CPAP adherence with and without financial incentive will have greater objectively measured average daily hours of CPAP use and greater improvement in functional outcomes following 3 months of treatment compared to patients receiving usual care. The results will test the hypothesis that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.

Key facts

Study ID

NCT01335854

Run by

University of Pennsylvania

People needed

135

Starts

2011-09-01

Expected to finish

2013-08-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years of age or older
• Apnea-hypopnea index (AHI) ≥ 10 events/hr on full-night in-laboratory polysomnogram (PSG) based on American Academic of Sleep Medicine (AASM) recommended scoring criteria
• Stable medical history and no change in medications, including anti-hypertensive, thyroid-related, and lipid-lowering medications, in the previous 2 months.
• Access to a telephone and the internet on all days of the week
• No regular use (> 3 times/week) of sedative or hypnotic medications in the last 2 months

You may not qualify if…

• Unable or unwilling to provide informed consent
• Are enrolled in other, ongoing clinical trials
• Inability to return for follow-up testing
• Previous diagnosis of another sleep disorder other than obstructive sleep apnea (OSA) (e.g., periodic limb movement disorder [≥ 15 limb movements/hr of sleep with arousal], central sleep apnea [≥ 50% of apneas on diagnostic PSG are central apneas], obesity hypoventilation syndrome, narcolepsy, or night eating syndrome
• Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other non-nasal surgery for OSA
• Requiring oxygen or bilevel positive airway pressure for treatment of OSA
• A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
• Systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg following 10 minutes at rest
• Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 3 months
• Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment)
• Inability to use CPAP due to claustrophobia, facial pathology, etc.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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