Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Hours of Sleep
研究概览
简要总结
This will be a double blinded randomized clinical trial carried out at Zale-Lipshy and Parkland Hospital Inpatient Rehabilitation Facilities. Acute stroke patients with insomnia, identified by the Insomnia Severity Index (ISI), and who choose to participate in this study will be randomized to CES (Cranial Electrical Stimulation) or sham CES. Patients who do not feel they are getting adequate sleep but want to continue in the study will be given the option to receive the standard of care medication as a rescue starting on the 3rd night.
Patients will receive treatment with a Fisher-Wallace CES device or Sham CES. Treatment with CES will be for 20 minutes once a day, and the treatment period will be for 7 days. Patients will be allowed to increase the intensity of the device from the suggested starting point of level 2 if they feel no improvement in sleep on night 1. Groups will be monitored with a wrist worn actigraph that records the patient's activity for the duration of the period of study and provides data on sleep latency, time spent asleep, and sleep efficiency. The outcome measures will be total minutes/hours of sleep, sleep efficiency and subjective reports of drowsiness using the Karolinska Sleepiness Scale. Actigraphic data will be collected 24 hours a day for 7 days. The total length of study will be about 24 months with a target N of 100 consented individuals and 85 participants. Patients will be allowed to exit the study at any time on their own choosing. To minimize loss of subjects, patients will have the option to choose SOC rescue starting on the third night. Patients who choose the SOC rescue will continue to be monitored with an actigraph for data collection purposes.
The investigator should discontinue study participation for a given subject or withdraw the subject from study if he/she believes that continuation would be detrimental to the subject's well-being. A subject can decide to withdraw from the study at any time and for any reason.
详细描述
The purpose of this study is to determine if CES is a reasonable first line alternative to the current standard of care (SOC) which relies on the use of trazodone for patients with subacute stroke. This objective will be answered by addressing the following:
• Specific Aim 1: To determine if stroke patients with insomnia who receive CES treatment sleep more hours than stroke patients treated with sham CES.
Hypothesis: Stroke patients with insomnia who are treated with CES will accumulate more sleeping hours than patients who are treated with sham CES.
• Specific Aim 2: To determine if stroke patients with insomnia who receive CES treatment have better sleep efficiency than stroke patients treated with sham CES.
Hypothesis: Stroke patients with insomnia who are treated with CES will demonstrate significantly better sleep efficiency than stroke patients treated with shame CES.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained.
- •Patients must be admitted to inpatient rehab.
- •Patients must have a documented acute stroke (ischemic, hemorrhagic or embolic).
- •Patients must have at least one fully functional arm which can be used to record actigraph data via a wrist worn actigraph device.
- •Subjects must Score a 7 or higher on the ISI.
- •Patients must be able to communicate consent and/or desire to discontinue the study.
- •Exclusion Criteria
- •Demand or sensing type cardiac pacemaker.
- •Known uncontrolled seizure disorder.
- •Current history of vertigo.
- •Need for continuous O
- •Inability to communicate or provide consent.
- •Restricted use or absence of both arms.
排除标准
- 未提供
结局指标
主要结局
Hours of Sleep
时间窗: 7- 24 hour periods
A wrist actigraph will record continuously for 7 days. Primary outcome hours of sleep
次要结局
- Sleep Efficiency(7-24 hour periods)
- Karolinska Sleepiness Scale(Daily for 7 days)
研究者
Amy Mathews
ASSISTANT PROFESSOR
University of Texas Southwestern Medical Center