Slow Wave Sleep and Inflammatory Processes in Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from baseline in nociception flexion reflex threshold
研究概览
简要总结
The purpose if the study is to determine whether improving sleep, especially slow wave or "deep" sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity and inflammatory responses to pain, and improves OA-related pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-75 years of age (for women, post-menopausal)
- •Kellgren-Lawrence grade II radiographic evidence of OA affecting one or both knees
- •knee pain on most days for ≥ 6 months
- •self-reported disability due to knee pain for ≥ 2 of the following: walking, kneeling, ascending or descending stairs, or performing daily activities
- •willing and able to avoid all prescription and non-prescription, non-opiate pain medication for 48 hours prior to testing and all narcotic pain medication for 2 weeks prior to testing
- •meets research diagnostic criteria for sleep maintenance insomnia
排除标准
- •health conditions with immunological components or undergoing or taking immunosuppressive therapies
- •conditions contraindicated for or potentially limiting ability to conduct NFR and/or cold pressor test (e.g. Raynaud's syndrome; seizures; prior MI; respiratory conditions; leg/hip nerve damage; BMI ≥ 32)
- •sleep disorders other than insomnia
- •dementia or cognitive impairment
- •history of schizophrenia or bipolar I disorder; current or recent history (within 3 months) of major psychiatric disorders
- •current depressive symptomatology or current suicidality
- •active substance dependence
- •untreated hypertension
- •use of antidepressants (stable use for 3 months okay), antipsychotics, mood stabilizers, sedative-hypnotics, opiate analgesics
结局指标
主要结局
Change from baseline in nociception flexion reflex threshold
时间窗: baseline and 10 weeks
Change from baseline in electrocutaneous pain threshold
时间窗: baseline and 10 weeks
Change from baseline in minutes of time in slow wave sleep
时间窗: baseline and 10 weeks
Change from baseline in relative power of delta EEG activity to index slow wave sleep activity
时间窗: baseline and 10 weeks
Change from baseline in inflammatory cytokine responses to pain
时间窗: baseline and 10 weeks
Change from baseline in Western Ontario and McMaster University OA Index
时间窗: baseline and 10 weeks
Change from baseline in Knee Pain Scale score
时间窗: baseline and 10 weeks
次要结局
未报告次要终点
研究者
Kathi Heffner
Associate Professor of Psychiatry
University of Rochester