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临床试验/NCT02484742
NCT02484742已完成不适用

Pain Sensitization and Habituation in a Model of Experimentally-induced Insomnia Symptoms

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Pain modulation

研究概览

简要总结

The main purpose of this study is to learn about the effects of repeated exposure to sleep disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep is shortened and disrupted, followed by a single night of recovery sleep) on inflammation, mood, and pain processing (experiences/perceptions of pain). Purpose of this research project is to understand the mechanisms of how sleep disruption may change mood and the experience of pain. Understanding those mechanisms is important to develop interventions that may help to reduce the effects of sleep disruption on mood and pain.

详细描述

  1. Screening Procedures: For this research study, the screening procedures include the following activities. Participants will first complete questionnaires and have an interview where they will be asked questions concerning general health status and sleep-wake habits. Also during this visit, a study nurse will collect a small blood sample that will be used to test for a number of markers of general health status.

If it appears that the participant may be eligible for participation, s/he will be introduced to an electronic diary that will be emailed every morning and evening to monitor sleep-wake patterns, mood, pain, and other health-related information.

Following the medical screening (visit 2), the physician will determine if the participant is eligible to proceed to the overnight sleep study. This consists of sleeping overnight in the laboratory during the usual sleep time.

Seven days before participation in the in-hospital portion of the study, a member of the study team will ask the participant to follow the study sleep-wake schedule. Sleep will be monitored with an electronic sleep diary and the participant will wear an actigraphy watch, which will help to evaluate sleep and measure the light level exposure before starting the study. 2. Randomization Procedures: Each participant will complete both parts of the study protocol, i.e., the experimental condition (where participants will undergo repeated cycles of sleep disruption, 18 days total in the Clinical Research Center) and the control condition (where participants will have a sleep opportunity of 8 hours every night; 18 days total in the Clinical Research Center). 3. Research Procedures: If a participant qualifies to take part in this research study, s/he will be required to stay in the hospital for two 18 day long research protocols. These protocols will take place at least 2-3 months apart. The experimental protocol includes 3 nights of 8 hour-sleep per night followed by three 4-day cycles, each consisting of 3 nights of shortened and disrupted sleep, followed by a single night of 8 hour recovery sleep. After the last cycle, the participant will have two more nights with 8 hours of sleep per night. In the control protocol, these 18 days will be 8-hour sleep nights.

During the stay in the hospital, research staff will accompany the participant during all waking times. The staff will help the participant to stay on the schedule, maintain wakefulness, and make sure that equipment is recording properly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Women and men between the ages 18-45 years.
  • Body mass index (BMI) between 18.5 and 30 kg/m
  • For female participants: regular menstrual cycles, no significant discomfort during pre-menses/menses.
  • Good quantity/quality sleep
  • Blood chemistry in the normal range.

排除标准

  • - Active infection/disease.
  • History of neurological, chronic pain, immune, cardiovascular, liver/kidney, or metabolic disorder.
  • History of psychiatric disorders, including major depressive disorders, bipolar disorders, panic disorders, post-traumatic stress disorders (PTSD), thought disorders, and substance abuse/dependence disorders.
  • Sleep disorders
  • Pregnant/nursing.
  • Regular medication use other than oral contraceptives.
  • Donation of blood or platelets 3 month prior to or in-between study arms.

研究组 & 干预措施

Sleep control condition

No Intervention

8 hours of sleep throughout the 18-day stay in the Clinical Research Center

Insomnia symptom induction condition

Experimental

4 4-day cycles, each consisting of 3 nights with sleep disruption followed by one night of recovery sleep.

干预措施: Insomnia symptom induction (Behavioral)

结局指标

主要结局

Pain modulation

时间窗: Followed for the duration of the two in-hospital stays, i.e. 2 x 18 days.

Sensitivity to heat and pressure pain, capacity to inhibit a painful stimulus when another painful stimuli is applied at the same time

Inflammatory markers

时间窗: Followed for the duration of the two in-hospital stays, i.e. 2 x 18 days.

Pro-inflammatory markers including cytokines (IL-6), prostaglandins (PGE2), measured in blood, urine, and saliva

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monika Haack

Assistant Professor of Neurology

Beth Israel Deaconess Medical Center

研究点 (2)

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