Promoting Continuous Positive Airway Pressure (CPAP) Adherence

NCT01335854 | Completed Early Phase 1

• 2 other identifiers: 812091RC2AG036592
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Apnea-hypopnea index; Continuous positive airway pressure; CPAP adherence

Outcome Measures

Primary Outcomes (2)

• Average daily hours of CPAP.

  Average daily hours of CPAP use determined objectively by the mask-on time recorded by the CPAP machine.

  3 months

• The change in the mean total score on the Functional Outcome of Sleep Questionnaire.

  The change in the mean total score on the Functional Outcome of Sleep Questionnaire (FOSQ-10), a validated, disease specific quality of life questionnaire.

  3 months

Secondary Outcomes (2)

• The percentage of days that the CPAP apparatus was used and the average daily hours of CPAP use on days used.

  3 months

• Total scores on the Epworth Sleepiness Scale (ESS) and the Medical Outcomes Study Short-Form-12 (SF-12).

  3 months

Study Arms (3)

Usual Care

NO INTERVENTION

Usual care for 3 months. This consists of a phone call after one week of treatment, and clinic appointments at the sleep center following one month and three months of CPAP treatment.

Web-Access to CPAP Data

EXPERIMENTAL

Usual care and web-based access to CPAP adherence data for 3 months. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website.

Behavioral: Web-based Access to CPAP Data

Web-Access to CPAP Data & Incentive

EXPERIMENTAL

Usual care and web-based access to CPAP data for 3 months with financial incentives. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website. Financial incentive terminated after 1 week.

Behavioral: Web-based Access to CPAP Data with Financial Incentive

Interventions

Web-based Access to CPAP Data BEHAVIORAL

Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the study, and then as frequently as they choose after the first week.

Web-Access to CPAP Data

Web-based Access to CPAP Data with Financial Incentive BEHAVIORAL

Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the the study, and then as frequently as they choose after the first week. There will be a payment of $30 during the first week for each day a participant uses CPAP for more than 4 hours the previous night and logs on to the website.

Web-Access to CPAP Data & Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Related Publications (3)

• Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.

  PMID: 19213683 BACKGROUND

• Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.

  PMID: 19066383 BACKGROUND

• Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.

  PMID: 19102784 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Samuel T Kuna, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 22, 2014

Record last verified: 2012-03

Locations

US (2)