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NCT Number: NCT06155916

Sleep and Neuropathic Pain - Intervention Study on Pregabalin

The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. To find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, iButtons, and ambulatory polysomnography in peripheral painful neuropathy patients. The main questions it aims to answer are:

* Is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance? * Does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? Participants will * Fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention * Before and after 1-month stabile pregabalin medication: 1-week Actiwatch monitoring, iButton (1 day and night), ambulatory polysomnography (1 night), brain fMRI.

Researchers will compare patients with high ISI score patients to see if they benefit more from pregabalin treatment than those with low ISI score.

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Key information

Conditions

Neuropathic Pain Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Helsinki, HUS, Finland

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About this study

This is a clinical study to analyze sleep and pain and their response to pregabalin in 40 patients aged 18 to 75 years with chronic (duration>3 months) moderate to severe pain (NRS ≥ 4/10) due to peripheral neuropathy. The investigators divide patients to two groups according to scores in ISI: the ones with clinically significant insomnia with score 15 or more (ISI High) and the ones without marked insomnia with score 14 or lower (ISI Low). Sleep will be assessed by a sleep diary, iButton, polysomnography and 1-week Actiwatch monitoring before and after 1-month stabile pregabalin dosage. Additionally, at these time points, several questionnaires regarding pain, sleep, mood, and quality of life and functional brain MRI will be performed. At pregabalin administration, the dose is added three to four day intervals, if tolerated by the patient. After a maximum tolerated dose has been stable for 1 month, the sleep studies, questionnaires, and brain fMRI are repeated. The study duration is about 3 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pregabalin

Drug

Pregabalin administration and titration to the highest dosage that the patient tolerates. The patient continues with the highest dose for one month and the pre-intervention studies are repeated.

Other names: Pregabalin for high insomnia patients with painful neuropathy, Pregabalin for low insomnia patients with painful neuropathy

Primary outcomes

  1. Pregabalin response to pain

    Time frame: Change from baseline pain intensity and interference immediately after the intervention

    Pain intensity and interference assessed by numeric rating scale

  2. Pregabalin effect on sleep stages

    Time frame: Change from baseline immediately after the intervention

    1-night Ambulatory Polysomnography (NREM stage III)

  3. Sleep disturbance associations to brain network connectivity

    Time frame: Change from baseline immediately after the intervention

    Brain fMRI for brain network connectivity

  4. Sleep disturbance associations to choroid plexus volume in brain fMRI

    Time frame: Change from baseline immediately after the intervention

    Brain fMRI for choroid plexus volume measures

  5. Pregabalin effect on circadian rhythms

    Time frame: Change from baseline immediately after the intervention

    1-week actigraphy

  6. Pregabalin effect on body temperature during sleep

    Time frame: Change from baseline immediately after the intervention

    1-night body temperature measurement by iButton

Study contacts

Contact information is provided by the study sponsor or research team.

Eija Kalso, PhD

CONTACT

[email protected]

+358504270609

Hanna Harno, PhD

CONTACT

[email protected]

+358503427375

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Official study title

Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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