Promoting Continuous Positive Airway Pressure (CPAP) Adherence

This is a nested clinical study in the NIH funded research project RC2AG036592, "Developing
Interactive Technology to Improve Research and Health Behavior". The purpose of the
research project is to create a web-based infrastructure to accelerate research in
behavioral economics to improve health. Failure to adhere to medical treatments is a major
cause of poor outcomes that increase health care spending. Changing unhealthful behaviors
is difficult. One barrier to behavioral change is the need to provide patients with
immediate, timely information about their behavior. Individual clinicians cannot maintain
the frequent contact that is required, but technology and automated feedback mechanisms can
keep these issues salient for patients. Internet technology is increasingly seen as an
appealing tool to overcome this barrier and promote patient self-management. Recent
evidence indicates that providing patients with web-based feedback of their health status
may improve adherence to treatment and outcomes.

Another barrier to behavioral change is that people need frequent reinforcement of positive
behavior and need that reinforcement often at the time they are making decisions (e.g., to
smoke, to overeat, to take medication). Recent studies report that the use of financial
incentives is an effective strategy to changing health behavior. Incentives in the form of
direct payments provide valuable positive reinforcement and have been shown to change health
behavior in a variety of contexts, including weight loss, medication adherence, and smoking
cessation. One criticism of this approach to changing health behaviors is whether the new
behavior is sustained once the financial incentive is withdrawn.

The proposed clinical study will use the web-based infrastructure that is developed by the
research project to evaluate the application of these emerging new approaches in behavioral
health intervention to improving CPAP adherence and consequent treatment outcomes in
patients with OSA. In the proposed research study, 120 patients with newly diagnosed OSA
who are being initiated on CPAP therapy will be randomized to one of three arms: 1) usual
care, 2) usual care with the ability of the participant to view reports of his/her daily
CPAP use on a password protected website, and 3) usual care with the ability of the
participant to view reports of his/her daily CPAP use on a password protected website
combined with a daily financial incentive in the first week based of hours per day of CPAP
use. The proposed health behavior interventions will 1) provide patients greater access to
information about their sleep disordered breathing, and 2) allow patients to become active
members of their management team. Aim 1 will determine if the proposed health behavior
interventions improve average daily hours of CPAP use in the first week and following 3
months of treatment. The overall hypothesis is 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.

Interventions designed to improve health-related behavior will only be justified if they
lead to greater improvements in clinically relevant outcomes. To determine the impact of
the proposed health behavior interventions to increase CPAP adherence on treatment outcomes,
Aim 2 will compare measures of daytime function following 3 months of CPAP treatment across
the three groups. The results of Aim 2 will demonstrate whether improvements in CPAP
adherence due to web-based feedback with or without a financial incentive result in greater
improvements in clinical outcomes.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.