Do Endotypes Predict Response and Sequelae in OSA Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Psychomotor Vigilance Test
研究概览
简要总结
This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 21-65 years old
- •Men and women with a physician diagnosis of OSA (or strongly suspected to have sleep apnea - * see below)
- •BMI 20 - 35 kg/m2
排除标准
- •Pregnancy (current or planned)
- •Inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in English.
- •Already on effective therapy and adherent to treatment for OSA
- •Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
- •Circadian rhythm disorder
- •Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
- •Uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >95)
- •Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.
- •Presence of tracheostomy
- •Hospitalization within the past 90 days
- •Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (< 5 years)
- •Prior gastric bypass surgery
- •Chronic liver disease or end-stage kidney disease
- •Active cancer
- •Allergy to any of the study drug
- •Regular use of medications known to affect control of breathing (opioids, sedatives/hypnotics including benzodiazepines, theophylline)
- •Chronically using study drug (Eszopiclone)
- •Active illicit substance use
- •Alcohol use of >1 standard drink/night for women or >2 standard drinks/night for men nightly alcohol use
- •Active smoking or vaping within the past 6 months
- •Psychiatric disease, other than controlled depression/anxiety
- •Prisoners
- •Subjects who are strongly suspected to have sleep apnea will be offered an overnight home sleep apnea test (HSAT) to verify OSA diagnosis.
研究组 & 干预措施
Early PAP Start
After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.
干预措施: Eszopiclone (Drug)
Usual PAP Start
After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will remain untreated until they are set up with their clinically prescribed CPAP (typically takes about 8 weeks).
干预措施: Eszopiclone (Drug)
Early PAP Start
After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.
干预措施: Continuous Positive Airway Pressure (CPAP) (Device)
Usual PAP Start
After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will remain untreated until they are set up with their clinically prescribed CPAP (typically takes about 8 weeks).
干预措施: Supplemental Oxygen (Other)
Early PAP Start
After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.
干预措施: Supplemental Oxygen (Other)
结局指标
主要结局
Psychomotor Vigilance Test
时间窗: 8 weeks
A 10-minutes, computerized reaction test asking subject to press a button every time a prompt appears. Faster times indicate better reactions and higher alertness.
Endothelial Dysfunction
时间窗: 8 weeks
Using a device called EndoPAT for a non-invasive bloodflow measure before, during, and after 5-minutes of occlusion to one arm. Differences in EndoPAT results will be compared between treatments.
次要结局
- Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)(8 weeks)
- Neurocognitive Assessment: NIH Toolbox(8 weeks)
- Insomnia Severity Index (ISI)(8 weeks)
- Beck Depression Index-II(8 weeks)
- Epworth Sleepiness Scale (ESS)(8 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(8 weeks)
- Richard's Campbell Sleep Questionnaire (RCSQ)(8 weeks)
- Brief Pain Inventory (Short Form)(8 weeks)
- Systolic Blood Pressure(8 weeks)
- Patient's Assessment of Own Function Inventory (PAOF) questionnaire(8 weeks)
- PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity(8 weeks)
- SF-36 Item Health Survey (SF-36)(8 weeks)
- Diastolic Blood Pressure(8 weeks)
- PROMIS (Patient-Reported Outcomes Measurement Information System) pain interference(8 weeks)
研究者
Atul Malhotra
Professor, Medicine
University of California, San Diego