A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea

NCT01164683 | Completed

• 1 other identifier: PPO 10-066
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and even death. The investigators plan to improve CPAP adherence in veterans through their interactions with peers who have successfully adopted CPAP therapy. Such "peer-buddies" may promote the well-being of veterans while remaining highly cost-effective when compared to healthcare providers. Our strategy is grounded on the rationale that veterans as a group are ecoculturally more homogenous than expected for the given level of differences in age, gender, ethnicity, or socioeconomic strata. Our long-term objectives are to initiate a larger, multi-site, research study for enhancing CPAP adherence in veterans with OSA. The ultimate goal of this research is to develop a cheap, effective and exportable system of care to promote CPAP adherence in patients with OSA.

Conditions

Sleep Apnea

Keywords

sleep apnea; adherence

Outcome Measures

Primary Outcomes (1)

• Functional Outcomes of Sleep Questionnaire (FOSQ)

  Three months

Secondary Outcomes (6)

• CPAP adherence

  Three months

• Patient Activation Measure (PAM) survey assessment tool

  Three months

• Self efficacy measure for sleep apnea

  Three months

• Psychomotor vigilance test

  three months

• Patient acceptability of peer-based intervention

  Three months

Study Arms (2)

Arm 1

EXPERIMENTAL

Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation).

Behavioral: Peer-driven intervention

Arm 2

ACTIVE COMPARATOR

Usual care

Other: Usual Care

Interventions

Peer-driven intervention BEHAVIORAL

Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation).

Also known as: Peer-buddy system (PBS)

Arm 1

Usual Care OTHER

All participants will receive usual care following initiation of CPAP therapy. Visits with respiratory therapist and sleep physician wherein patients are educated about the basics of the care and operation of the device, mask and related equipment. Subsequently, their CPAP adherence is monitored and appropriate interventions such as mask change and re-education undertaken as needed.

Arm 2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obstructive Sleep Apnea (defined by Apnea-hypopnea index \[AHI\] \> 5 per hour; with hypopneas defined as greater than 30% reduction in airflow with 4 or greater drop in oxygen saturation). AHI will be determined by full night or split-night polysomnography.
• Age range 21 - 85 years old.
• Stable medical history and no change in medications, including anti-hypertensive and thyroid replacement, in the previous 4 months.
• No regular use (\> 3 times/week) of sedative or hypnotic medications in the last 4 months.

You may not qualify if:

• Central sleep apnea (central apnea index \> 5 per hour and \>50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
• Complex sleep apnea or CPAP emergent central apnea (Central apnea index \> 5 per hour during CPAP titration with \>50% of Apnea-hypopnea index constituted by central apneas and non-obstructive hypopneas).
• Requiring oxygen or bi-level positive airway pressure for treatment of OSA or hypoventilation.
• Decompensated cardiac (heart failure or angina) or pulmonary (severe COPD or uncontrolled asthma) disease
• Chronic narcotic use
• Nasal obstruction (nasal congestion score \> 15) or enlarged tonsils
• Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodic limb movement disorder \[ 15 limb movements/hour of sleep with arousal\], central sleep apnea \[ 50% of apneas on diagnostic PSG are central apneas\], insomnia, obesity hypoventilation syndrome, or narcolepsy).
• Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other surgery for OSA.
• Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months.
• Routine consumption of more than 2 alcoholic beverages per day.
• Recent or recurring history of recreational drug use leading to tolerance or dependence.
• Unable to perform tests due to inability to communicate verbally, inability to write and read in English; 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).

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723, United States

Location

Related Publications (2)

• Parthasarathy S. The need for pharmacovigilance in sleep medicine. Sleep. 2011 Jul 1;34(7):827-8. doi: 10.5665/SLEEP.1096. No abstract available.

  PMID: 21731126 BACKGROUND

• Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2013 Jun 15;9(6):543-50. doi: 10.5664/jcsm.2744.

  PMID: 23772186 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Sairam Parthasarathy, MD

  Southern Arizona VA Health Care System, Tucson, AZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: July 19, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 7, 2015

Record last verified: 2013-02

Locations

US (1)