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Study on the Effect of Pregabalin on Sleep and Pain in Patients with Neuropathic Pain

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication pregabalin on patients experiencing neuropathic pain. Neuropathic pain is a type of chronic pain that occurs when nerves in the body are damaged or not working properly. The study aims to understand how pregabalin affects sleep patterns and pain levels in these patients. Pregabalin is available in different forms, including Pregabalin Pfizer 150 mg hard capsules, Lyrica 25 mg hard capsules, and Lyrica 75 mg hard capsules. These medications are taken orally, meaning they are swallowed in capsule form.

The purpose of the study is to analyze sleep and its detailed structure in patients with neuropathic pain, both with and without significant sleep disturbances, before and during treatment with pregabalin. Participants will be monitored for changes in their sleep stages, brain activity, and body temperature during sleep. The study will also explore how sleep disturbances relate to brain connectivity and other brain features using techniques like fMRI, which is a type of brain scan that measures brain activity by detecting changes associated with blood flow.

Throughout the study, participants will undergo various assessments, including a one-night sleep study called ambulatory polysomnography, which records brain waves, oxygen levels, heart rate, and breathing during sleep. Additionally, the study will use devices like the OURA-ring and iButton to track sleep patterns and body temperature over a week. The study is expected to provide valuable insights into how pregabalin can help manage pain and improve sleep quality in patients with neuropathic pain.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating the presence of peripheral neuropathic pain and assessing sleep disturbances using the ISI-questionnaire.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to understand current pain levels and sleep patterns. This involves using a numeric rating scale for pain and possibly a sleep questionnaire.

  3. Step 3

    Medication administration

    Participants begin taking pregabalin in the form of hard capsules. The specific dosages used in the study are 25 mg, 75 mg, and 150 mg. The medication is taken orally, as prescribed by the study protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the study, participants are monitored for changes in pain intensity and sleep quality. This includes regular assessments using the numeric rating scale and other tools.

  5. Step 5

    Sleep analysis

    Participants undergo a 1-night ambulatory polysomnography to analyze sleep stages, particularly focusing on NREM stage III. This helps in understanding the effect of pregabalin on sleep structure.

  6. Step 6

    Brain connectivity and volume assessment

    Brain fMRI scans are conducted to study the associations between sleep disturbances and brain network connectivity, as well as choroid plexus volume.

  7. Step 7

    Circadian rhythm and body temperature monitoring

    Participants' circadian rhythms are monitored over a week using actigraphy and an OURA-ring. Additionally, body temperature during sleep is measured for one night using an iButton device.

  8. Step 8

    Final evaluation

    At the end of the study, a final evaluation is conducted to assess the overall response to pregabalin in terms of pain relief and sleep improvement.

Who can join the trial?

6 criteria

  • Patients must have **peripheral neuropathic pain**, which means pain caused by damage to the nerves outside the brain and spinal cord.
  • Patients should be between the ages of 18 and 75 years old.
  • The pain must be **chronic**, meaning it has lasted for more than 3 months.
  • The pain should be of **moderate to severe intensity**, which is measured as a score of 4 or higher on a scale from 0 to 10.
  • Patients should have either a moderate sleep disturbance, as measured by a specific questionnaire called the ISI-questionnaire, with a score greater than 14, or no sleep disturbance at all.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

3 criteria

  • Patients who do not have persistent peripheral neuropathic pain. Peripheral neuropathic pain is a type of pain that happens when nerves outside the brain and spinal cord are damaged.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population. A vulnerable population includes groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Pregabalin is a medication used in this clinical trial to help manage neuropathic pain and improve sleep quality in patients. It works by calming the nerves and reducing pain signals in the brain, which may also help patients sleep better.

What is already known about the treatment

Pregabalin – Pregabalin is administered orally, typically in the form of capsules or oral solution. It is currently well-established in medical practice and literature as a treatment for neuropathic pain, among other conditions. The main therapeutic indication for pregabalin in this context is the management of persistent peripheral neuropathic pain. At the molecular level, pregabalin works by binding to certain calcium channels in the nervous system, which helps to reduce the release of neurotransmitters involved in pain transmission. It is classified pharmacologically as an anticonvulsant and neuropathic pain agent.

Investigated diseases

Peripheral Neuropathic Pain – Peripheral neuropathic pain is a condition characterized by persistent pain resulting from damage or dysfunction of the peripheral nerves. This type of pain is often described as burning, tingling, or shooting in nature. It can occur in various parts of the body, depending on which nerves are affected. The pain may be constant or intermittent and can vary in intensity. Over time, it can lead to significant discomfort and may interfere with daily activities. The condition is not classified as a rare disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515820-35-02Protocol code2024-515820-35-00Estimated enrolment40 patientsSponsorHUS-yhtymae

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