Examining the effects of pregabalin on sleep and pain in neuropathic pain patients
Official title: Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
Run by Helsinki University Central Hospital · NCT06155916 · Data updated 2026-11-12
This study is testing how pregabalin affects sleep and pain in people with chronic neuropathic pain to see if it helps them feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 2 sites (Helsinki, HUS and 1 other locations) |
| Status | Recruiting |
| Started | November 22, 2022 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | March 14, 2025 |
| Trial ID | NCT06155916 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with chronic peripheral neuropathy and moderate to severe pain.
✕Probably not a fit
Patients with psychotic depression or significant bipolar disorder, or those who cannot undergo fMRI, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study investigates the relationship between sleep quality and neuropathic pain in patients undergoing treatment with pregabalin. It involves 40 participants aged 18 to 75 with chronic moderate to severe pain due to peripheral neuropathy, who are divided into two groups based on their insomnia severity. The study assesses sleep through various methods, including sleep diaries and polysomnography, before and after one month of stable pregabalin dosage. Additionally, brain connectivity and volume changes will be evaluated using fMRI to understand the impact of pain and sleep disturbances.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for neuropathic pain patients suffering from sleep disturbances.
How similar studies have gone: Previous studies have shown promising results in the efficacy of pregabalin for neuropathic pain, but this specific focus on sleep quality is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic (duration \> 3 months) painful peripheral neuropathy * Pain moderate to severe (NRS ≥ 4/10) during the past week Exclusion Criteria: * psychotic depression, clinically significant bipolar disorder * contraindication for performing brain fMRI (metal in the body etc)
Where it's running
-
Helsinki University Central Hospital
Helsinki, Hus, Finland Recruiting -
Helsinki University Hospital, Department of Neurology
Helsinki, Uusimaa, Finland Recruiting
Study contacts
- Study coordinator: Hanna Harno, PhD
- Email: hanna.harno@hus.fi
- Phone: +358503427375
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.