Status:
COMPLETED
A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Sleep Apnea
Eligibility:
All Genders
21-85 years
Phase:
NA
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 (CPA...
Detailed Description
Project background: Obstructive sleep apnea (OSA) is a prevalent condition that is most frequently treated with continuous positive airway pressure (CPAP) therapy. Non-adherence to such therapy, howev...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01164683
Start Date
July 1 2010
End Date
June 1 2012
Last Update
April 7 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723