Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
Pregabalin
Mental Disorders+10
+ Sleep Initiation and Maintenance Disorders
+ Nervous System Diseases
Treatment Study
Summary
Study start date: November 22, 2022
Actual date on which the first participant was enrolled.The study focuses on understanding how sleep and pain are affected by the medication pregabalin in adults aged 18 to 75 who suffer from chronic peripheral neuropathy. Participants have been experiencing moderate to severe pain for more than three months. This study aims to discover how pregabalin, a drug often used for managing nerve pain, can influence not only pain levels but also sleep quality and patterns. The research is important as it seeks to address how chronic pain and sleep disturbances are related and whether treatment with pregabalin can improve these conditions, potentially leading to better quality of life for patients with neuropathic pain. Participants are divided into two groups based on their level of insomnia. Those with significant insomnia and those with less severe sleep issues undergo various tests to monitor their sleep and pain. Sleep is tracked through diaries, wearable devices like the Actiwatch, and detailed studies like polysomnography. Pregabalin is administered gradually over a few days until a stable dose is reached, which is then maintained for a month. Throughout the study, questionnaires assess pain, mood, and life quality, while brain activity is analyzed using MRI scans. After a month of stable medication use, the tests are repeated to compare changes. This process helps determine the effectiveness of pregabalin on improving sleep and reducing pain.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Helsinki University Central Hospital
Helsinki, FinlandOpen Helsinki University Central Hospital in Google MapsHelsinki University Hospital, Department of Neurology
Helsinki, Finland