Sleep and Neuropathic Pain - Intervention Study on Pregabalin

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Chronic (duration > 3 months) painful peripheral neuropathy

Pain moderate to severe (NRS ≥ 4/10) during the past week

Disqualifiers

psychotic depression, clinically significant bipolar disorder

contraindication for performing brain fMRI (metal in the body etc)

Trial design

Treatments tested in this trial

  • Pregabalin

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Helsinki University Central Hospital

Lead sponsor

University of Helsinki

Collaborator