Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain

Helsinki University Central Hospital2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2022年11月22日最近更新: 2025年3月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Helsinki University Central Hospital
入组人数: 40
试验地点: 2
主要终点: Pregabalin response to pain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. To find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, iButtons, and ambulatory polysomnography in peripheral painful neuropathy patients. The main questions it aims to answer are:

Is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance?
Does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? Participants will
Fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention
Before and after 1-month stabile pregabalin medication: 1-week Actiwatch monitoring, iButton (1 day and night), ambulatory polysomnography (1 night), brain fMRI.

Researchers will compare patients with high ISI score patients to see if they benefit more from pregabalin treatment than those with low ISI score.

详细描述

This is a clinical study to analyze sleep and pain and their response to pregabalin in 40 patients aged 18 to 75 years with chronic (duration>3 months) moderate to severe pain (NRS ≥ 4/10) due to peripheral neuropathy. The investigators divide patients to two groups according to scores in ISI: the ones with clinically significant insomnia with score 15 or more (ISI High) and the ones without marked insomnia with score 14 or lower (ISI Low). Sleep will be assessed by a sleep diary, iButton, polysomnography and 1-week Actiwatch monitoring before and after 1-month stabile pregabalin dosage. Additionally, at these time points, several questionnaires regarding pain, sleep, mood, and quality of life and functional brain MRI will be performed. At pregabalin administration, the dose is added three to four day intervals, if tolerated by the patient. After a maximum tolerated dose has been stable for 1 month, the sleep studies, questionnaires, and brain fMRI are repeated. The study duration is about 3 months.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Chronic (duration > 3 months) painful peripheral neuropathy
•Pain moderate to severe (NRS ≥ 4/10) during the past week

排除标准

•psychotic depression, clinically significant bipolar disorder
•contraindication for performing brain fMRI (metal in the body etc)

研究组 & 干预措施

High ISI

Experimental

Patients that have clinically significant insomnia according to ISI questionnaire (score 15 or more) at baseline.

干预措施: Pregabalin (Drug)

Low ISI

Experimental

Patients with no clinically significant insomnia according to ISI questionnaire (score 14 or less) at baseline.

干预措施: Pregabalin (Drug)

结局指标

主要结局

Pregabalin response to pain

时间窗: Change from baseline pain intensity and interference immediately after the intervention

Pain intensity and interference assessed by numeric rating scale

Pregabalin effect on body temperature during sleep