Sleep and Neuropathic Pain - Intervention Study on Pregabalin

Recruiting now · Not applicable

Conditions studied: Neuropathic Pain, Insomnia, Sleep Disorder

In brief

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.

Key facts

Study ID

NCT06155916

Run by

Helsinki University Central Hospital

People needed

40

Starts

2022-11-22

Expected to finish

2026-12-01

Last updated by the study team

2025-03-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Helsinki University Central Hospital — Helsinki, HUS, Finland (enrolling)
• Helsinki University Hospital, Department of Neurology — Helsinki, Uusimaa, Finland (enrolling)

Full record on ClinicalTrials.gov

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