Clinical trial Recruiting at 2 sites Interventional Ages 18 to 75

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.

More Insomnia trials

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment40 (estimated)
SponsorHelsinki University Central Hospital
Academic / other
Locations2 sites (Helsinki, HUS and 1 other locations)
StatusRecruiting
StartedNovember 22, 2022
Main results expectedDecember 2025
Study endsDecember 2026
Registry record updatedMarch 14, 2025
Trial IDNCT06155916 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Comparing two therapies for insomnia treatment

    This study is testing whether a new sleep therapy called Bedtime Restriction Therapy works just as well as the more common Cognitive Behavioral Therapy for Insomnia to help adults with insomnia sleep better.

    Recruiting at 2 sites University of Geneva, Switzerland · Bern, Canton of Bern and 1 other locations · NCT06767137

  • Transanal irrigation for sleep issues after rectal cancer surgery

    This study tests if a treatment called transanal irrigation can help adults with sleep problems after surgery for rectal cancer feel better and improve their sleep.

    Recruiting Seoul National University Hospital · Seoul, Jongro-gu · NCT06222255

  • Registry of patients with sleep disorders

    This study is collecting information from people with sleep disorders to see how these conditions affect their lives and to track their progress over time.

    Recruiting Johannes Gutenberg University Mainz · Mainz, Rhineland-Palatinate · NCT05321355

  • Digital platform for treating insomnia with cognitive-behavioral therapy

    This study is testing a digital program that uses therapy to help people aged 20 to 60 with mild insomnia sleep better compared to traditional treatments.

    Recruiting SleepUp Tecnologia em Saúde Ltda · São Caetano do Sul, São Paulo · NCT04949360

  • SleepCogni for children with chronic insomnia

    A handheld SleepCogni device is tested to see if it helps kids aged 6–16 with chronic insomnia sleep better.

    Recruiting Sheffield Children's NHS Foundation Trust · Sheffield · NCT07926724

  • Music therapy after stroke

    This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.

    Recruiting Universidad de Granada · Granada, Granada · NCT07899034

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.