Actively Recruiting
Sleep and Neuropathic Pain - Intervention Study on Pregabalin
Led by Helsinki University Central Hospital · Updated on 2025-03-14
40
Participants Needed
2
Research Sites
210 weeks
Total Duration
On this page
Sponsors
H
Helsinki University Central Hospital
Lead Sponsor
U
University of Helsinki
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sleep and Neuropathic Pain - Intervention Study on Pregabalin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic painful peripheral neuropathy lasting more than 3 months
- Moderate to severe pain with Numeric Rating Scale (NRS) of 4 or higher during the past week
You will not qualify if you...
- Psychotic depression or clinically significant bipolar disorder
- Contraindications for brain MRI such as metal in the body
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029
Actively Recruiting
2
Helsinki University Hospital, Department of Neurology
Helsinki, Uusimaa, Finland, 00029
Actively Recruiting
Research Team
H
Hanna Harno, PhD
CONTACT
E
Eija Kalso, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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