Sleep, Pain and Aging: Potential Underlying Mechanisms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline
研究概览
简要总结
Chronic pain is a serious public health problem in older adults depending on the pain condition, and the capacity to sleep properly changes with age. Given the potential mechanistic role of GABA (gamma-aminobutyric acid) in both conditions, based on our preliminary data, this proposal will determine the effect of oral GABA administration in sleep quality and pain in older adults with chronic pain and sleep disorders as well as to characterize the potential neurobiological mechanisms involved in both illnesses.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults 45 years of age or older who experienced pain of at least moderate intensity (>5/10 pain intensity ratings) on more days than not during the past three months, and who also reported poor sleep quality (>5 PSQI scores) will be considered for participation.
排除标准
- •serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder;
- •history of alcohol/drug abuse;
- •Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions;
- •significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination [3MS] score ≤ 77;
- •hospitalizations for mental health reasons in the past year;
- •chronic/current use of narcotic medications;
- •serious systemic (uncontrolled diabetes self-reported HA1C>7), (uncontrolled hypertension > 155/90 mm Hg) and rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia, HIV);
- •arterial hypotension;
- •digestive tract diseases;
- •major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures;
- •excessive anxiety regarding protocol procedures;
- •Inability to consent for study participation;
- •Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others);
- •Neuropathic pain medications including anticonvulsants and antidepressants;
- •Allergies or sensitivity to GABA or its ingredients cellulose' gelatin (capsule)' magnesium silicate' vegetable stearate and silica or to the placebo or its ingredients: calcium laurate, hypromellose capsule, magnesium (citrate), microcrystalline cellulose;
- •currently taking barbiturate and benzodiazepine and baclofen;
- •MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia;
- •current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and
研究组 & 干预措施
Daily Oral GABA
You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks
干预措施: GABA (Dietary Supplement)
Daily Placebo
You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline
时间窗: PSQI was administered at baseline
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention
时间窗: PSQI was administered immediately after completing the 4-week intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
Verbal Descriptor Scale (VDS) at Baseline
时间窗: VDS was administered at baseline
The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline
时间窗: WOMAC was administered at baseline.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.
Verbal Descriptor Scale (VDS) at Post-Intervention
时间窗: VDS was administered immediately after completing the 4-week intervention
The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention
时间窗: WOMAC was administered after completing the 4-week intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.
次要结局
- Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline(Baseline)
- Pain Detect at Baseline(Baseline)
- Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline(Baseline)
- Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention(Immediately post-intervention (4 weeks))
- Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention(Immediately post-intervention (4 weeks))
- Pain Detect at Post-Intervention(Immediately post-intervention (4 weeks))
- Epworth Sleepiness Scale (ESS) at Baseline(Baseline)
- Epworth Sleepiness Scale (ESS) at Post-Intervention(Immediately post-intervention (4 weeks))