2024-515820-35-02招募中4 期
Sleep structure in neuropathic pain patients, psychological factors, brain connectivity, and the effect of pregabalin on sleep and pain
HUS-Yhtymae1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月14日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pregabalin response to pain. Pain intensity and interference assessed by numeric rating scale
研究概览
简要总结
To analyse sleep and its microstructure in neuropathic pain patients who have or who do not have a major sleep disturbance, before and during treatment with pregabalin.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with peripheral painful neuropathy, age 18-75 years, pain is chronic (duration >3 months) and moderate to severe intensity (NRS ≥ 4/10) aiming to recruit 20 patients with at least a moderate sleep disturbance as assessed with ISI-questionnaire (>14) and 20 patients without sleep disturbance.
排除标准
- •Excessive alcohol consumption (>7 doses/week). If the patient uses gabapentinoids (gabapentin or pregabalin), they are discontinued 2 weeks before the study. Psychotic depression, clinically significant bipolar disorder. Contraindications to brain fMRI.
结局指标
主要结局
Pregabalin response to pain. Pain intensity and interference assessed by numeric rating scale
Pregabalin response to pain. Pain intensity and interference assessed by numeric rating scale
次要结局
- Pregabalin effect on sleep stages. 1-night Ambulatory Polysomnography (NREM stage III).
- Sleep disturbance associations to brain network connectivity. Brain fMRI for brain network connectivity
- Sleep disturbance associations to choroid plexus volume in brain fMRI. Brain fMRI for choroid plexus volume measures
- Pregabalin effect on circadian rhythms. 1-week actigraphy and OURA-ring
- Pregabalin effect on body temperature during sleep. 1-night body temperature measurement by iButton
研究者
Hanna Harno
Scientific
HUS-Yhtymae
研究点 (1)
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