Recruiting

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Pregabalin

Drug
Who is being recruted

Mental Disorders+10

+ Sleep Initiation and Maintenance Disorders

+ Nervous System Diseases

From 18 to 75 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2022
See protocol details

Summary

Principal SponsorHelsinki University Central Hospital
Study ContactHanna Harno, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 22, 2022

Actual date on which the first participant was enrolled.

The study focuses on understanding how sleep and pain are affected by the medication pregabalin in adults aged 18 to 75 who suffer from chronic peripheral neuropathy. Participants have been experiencing moderate to severe pain for more than three months. This study aims to discover how pregabalin, a drug often used for managing nerve pain, can influence not only pain levels but also sleep quality and patterns. The research is important as it seeks to address how chronic pain and sleep disturbances are related and whether treatment with pregabalin can improve these conditions, potentially leading to better quality of life for patients with neuropathic pain. Participants are divided into two groups based on their level of insomnia. Those with significant insomnia and those with less severe sleep issues undergo various tests to monitor their sleep and pain. Sleep is tracked through diaries, wearable devices like the Actiwatch, and detailed studies like polysomnography. Pregabalin is administered gradually over a few days until a stable dose is reached, which is then maintained for a month. Throughout the study, questionnaires assess pain, mood, and life quality, while brain activity is analyzed using MRI scans. After a month of stable medication use, the tests are repeated to compare changes. This process helps determine the effectiveness of pregabalin on improving sleep and reducing pain.

Official TitleSleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
NCT06155916
Principal SponsorHelsinki University Central Hospital
Study ContactHanna Harno, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSleep Initiation and Maintenance DisordersNervous System DiseasesNeuralgiaNeurologic ManifestationsNeuromuscular DiseasesPainPeripheral Nervous System DiseasesSigns and SymptomsSleep Wake DisordersPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomnias

Criteria

2 inclusion criteria required to participate
Chronic (duration > 3 months) painful peripheral neuropathy

Pain moderate to severe (NRS ≥ 4/10) during the past week

2 exclusion criteria prevent from participating
psychotic depression, clinically significant bipolar disorder

contraindication for performing brain fMRI (metal in the body etc)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Helsinki University Central Hospital

Helsinki, FinlandOpen Helsinki University Central Hospital in Google Maps
Recruiting

Helsinki University Hospital, Department of Neurology

Helsinki, Finland
Recruiting
2 Study Centers