NCT03984058已完成不适用
Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR)
研究概览
简要总结
Recruitment strategies comparing different strategies.
详细描述
Patients with prediabetes and moderate-to-severe Obstructive Sleep Apnea (OSA). To determine the recruitment yields from electronic medical record (EMR) vs the general community. To assess the adherence to positive airway pressure (PAP) therapy among patients with prediabetes and moderate-to-severe OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prediabetes: A1c value of 6.0-6.4% and fasting glucose of 100-125 mg/dl
- •Moderate-to-severe OSA [4% oxygen desaturation index (ODI) ≥ 20/h]
- •Ability to provide informed consent
- •Able to comply with all study procedures and be available for the study duration
- •Availability of smart phone
排除标准
- •BMI < 28 or ≥ 38 kg/m2
- •Type 1 or Type 2 diabetes mellitus
- •Pregnancy
- •Use of glucose-lowering or weight loss medications (e.g., metformin, orlistat, phentermine)
- •Prior or anticipated bariatric surgery
- •Current use of PAP or oral appliance therapy for OSA
- •Commercial driver
- •Report of a motor vehicle accident or near-miss due to sleepiness within 2 years
- •Epworth Sleepiness Scale score10 > 18
- •Current (prevalent) use of oral corticosteroids (within 1 month)
- •Participation in a concurrent clinical trial
- •Unstable medical conditions: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension [BP ≥ 160/100 among those with hypertension, requiring 3 or more meds], severe chronic obstructive pulmonary disease, cancer, or active psychiatric disease
- •Other sleep disorders (e.g., circadian rhythm disorder, working night or rotation shift, short sleep duration based on self-reported habitual sleep patterns < 5 hrs/night)
- •Use of supplemental oxygen during wakefulness or sleep
- •Central sleep apnea (central apnea index ≥ 5/h) or Cheyne-Stokes respiration (> 10 minutes of continues period breathing) on the screening home sleep test Resting awake SpO2 < 90%
- •Chronic opiate use.
- •Use of illicit drug / marijuana use more than once per week
- •Difficulty understanding or speaking English
- •Anything that, in the opinion of the site investigator, would place the participant at increased risk or preclude a participant's ability to adhere to study protocols or complete the study
结局指标
主要结局
Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR)
时间窗: 1 year
Determine recruitment yield from EMR versus the general community.
次要结局
- Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system(1 Week)
研究者
研究点 (2)
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