Ramelteon for Insomnia Comorbid With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.
详细描述
Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 - 60 with both insomnia and asthma.
- •Insomnia:
- •a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality,
- •the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and
- •at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months.
- •Additional inclusion criteria include: a subjective TST <6.5 h and a subjective SL > 45 min per night; a mean LPS >20 min over 2 consecutive nights by polysomnography (neither night could have been <15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score > 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep.
- •Asthma will be diagnosed based on suggestive clinical history and either
- •airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less
- •bronchodilator-responsive expiratory airflow limitation (if FEV1 < 70% of predicted value or < 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score < 1.5.
排除标准
- •Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI > 15), periodic leg movements (movement arousal index > 15), REM behavior disorder; or circadian sleep-wake disorders
- •History of cognitive or other neurological disorders;
- •History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;
- •Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;
- •Unstable or serious medical conditions;
- •Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);
- •Shift work or other types of self imposed irregular sleep schedules;
- •Obesity (BMI > 35 Kg/m2); or
- •Pregnancy or desire to become pregnant during the study.
研究组 & 干预措施
1: Ramelteon
干预措施: Ramelteon (Drug)
2: Placebo
干预措施: Ramelteon (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: baseline and post-treatment (at end of 5 weeks)
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Insomnia Severity Index
时间窗: 5 weeks
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
次要结局
- Daytime Sleepiness (Epworth Sleepiness Scale)(baseline and post-treatment (at end of 5 weeks))
- Daytime Performance (Digit Symbol Substitution Test)(baseline and post-treatment (at end of 5 weeks))
- Daytime Lung Function (Peak Flow Monitoring) in Liter/Min(baseline and during treatment period (during 5th week))
研究者
Brandon Lu
Physician
Northwestern University