Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
研究概览
简要总结
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
详细描述
The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment.
Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life.
They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sarcoidosis using standard criteria
- •Disease for more than one year
- •On stable, systemic therapy
- •Complain of fatigue which has been present for more than six months.
- •Over 18 years of age
- •Provide written informed consent.
排除标准
- •Pregnancy
- •Change in therapy for sarcoidosis in prior three months
- •History of ventricular arrythmias
研究组 & 干预措施
Armnodafinil
Armodafinil
干预措施: Armodafinil (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
时间窗: Prospective
次要结局
- To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.(Prospective)
- To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.(Prospective)
研究者
Robert P Baughman
Prof Medicine
University of Cincinnati