Sleep and Neuropathic Pain - Intervention Study on Pregabalin

NCT06155916 | Recruiting

• 1 other identifier: TYH2020214
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neuropathic Pain; Insomnia; Sleep Disorder

Keywords

polysomnography; actigraphy; fMRI; pregabalin; neuropathic pain

Outcome Measures

Primary Outcomes (6)

• Pregabalin response to pain

  Pain intensity and interference assessed by numeric rating scale

  Change from baseline pain intensity and interference immediately after the intervention

• Pregabalin effect on sleep stages

  1-night Ambulatory Polysomnography (NREM stage III)

  Change from baseline immediately after the intervention

• Sleep disturbance associations to brain network connectivity

  Brain fMRI for brain network connectivity

  Change from baseline immediately after the intervention

• Sleep disturbance associations to choroid plexus volume in brain fMRI

  Brain fMRI for choroid plexus volume measures

  Change from baseline immediately after the intervention

• Pregabalin effect on circadian rhythms

  1-week actigraphy

  Change from baseline immediately after the intervention

• Pregabalin effect on body temperature during sleep

  1-night body temperature measurement by iButton

  Change from baseline immediately after the intervention

Study Arms (2)

High ISI

EXPERIMENTAL

Patients that have clinically significant insomnia according to ISI questionnaire (score 15 or more) at baseline.

Drug: Pregabalin

Low ISI

EXPERIMENTAL

Patients with no clinically significant insomnia according to ISI questionnaire (score 14 or less) at baseline.

Drug: Pregabalin

Interventions

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.

Also known as: Pregabalin for high insomnia patients with painful neuropathy, Pregabalin for low insomnia patients with painful neuropathy

High ISI; Low ISI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic (duration \> 3 months) painful peripheral neuropathy
• Pain moderate to severe (NRS ≥ 4/10) during the past week

You may not qualify if:

• psychotic depression, clinically significant bipolar disorder
• contraindication for performing brain fMRI (metal in the body etc)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (2)

Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

RECRUITING

Helsinki University Hospital, Department of Neurology

Helsinki, Uusimaa, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Neuralgia; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hanna Harno, PhD

  Helsinki University Hospital, Department of Neurology

  STUDY CHAIR

Central Study Contacts

Hanna Harno, PhD

CONTACT

+358503427375; hanna.harno@hus.fi

Eija Kalso, PhD

CONTACT

+358504270609; eija.kalso@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Patients start with pregabalin at dose 25mg-75mg per day according to their preference and dose will be added by 25mg to 75 mg/ 4 days up to the highest dosage the patient tolerates (maximum 300mg twice daily). After having pregabalin stabile for one month with the highest tolerated dosage, post-examinations are repeated while still using pregabalin.

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: December 5, 2023
• Study Start: November 22, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

FI (2)