Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06155916

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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