Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of hours patient adhered to PAP therapy
研究概览
简要总结
The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Moderate-to-severe OSA
- •Available to attend study visits and sessions
- •Reliable access to a phone
排除标准
- •Prior or current use of PAP therapy or other treatment (e.g., oral appliance) for OSA
- •History of upper airway surgery for OSA
- •Moderate to severe insomnia
- •Commercial drivers
- •Use of non-standard PAP including adaptive servo-ventilation or bi-level positive airway pressure
- •Report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
- •Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
- •Other sleep disorders (e.g., circadian rhythm disorder)
- •Use of supplemental oxygen during wakefulness or sleep
- •Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep apnea test
- •Resting awake oxygen saturation (SpO2) < 90%
- •Participation in another clinical trial
研究组 & 干预措施
Motivational Enhancement Therapy (MET)
Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.
干预措施: Motivational Enhancement Therapy (Behavioral)
Motivational Enhancement Therapy (MET)
Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.
干预措施: Positive Airway Pressure (PAP) therapy (Device)
PAP therapy
Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months.
干预措施: Positive Airway Pressure (PAP) therapy (Device)
结局指标
主要结局
Number of hours patient adhered to PAP therapy
时间窗: 3 months
Measured in the number of hours of use of PAP therapy
次要结局
- Epworth Sleepiness Scale Score(3 months)
- Blood pressure(3 months)
- Mean Glucose Level(3 months)
研究者
Naresh Punjabi
Professor
University of Miami