Examining the effects of pregabalin on sleep and pain in neuropathic pain patients
Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 2 sites (Helsinki, HUS and 1 other locations) |
| Trial ID | NCT06155916 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with chronic peripheral neuropathy and moderate to severe pain.
Not a fit: Patients with psychotic depression or significant bipolar disorder, or those who cannot undergo fMRI, may not benefit from this study.
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 performed: Previous studies have shown promising results in the efficacy of pregabalin for neuropathic pain, but this specific focus on sleep quality is relatively novel.
Eligibility criteria
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 this trial is running
Helsinki, HUS and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.