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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hwhppqts Uswckpcgwu Cypawcd Hkedflog	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	22.11.2022

Trial locations

Investigated drugs:

Pregabalin

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.

Investigated diseases:

Neuralgia

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 ID:

2024-515820-35-02

Protocol code:

2024-515820-35-00

NCT ID:

NCT06155916

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?