Sleep and Neuropathic Pain - Intervention Study on Pregabalin
Key facts
- Who runs it
- Helsinki University Central Hospital
- Where
- Helsinki, FinlandSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 22 Nov 2022
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Pregabalin
- Record updated
- 14 March 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Chronic (duration > 3 months) painful peripheral neuropathy
- Pain moderate to severe (NRS ≥ 4/10) during the past week
Who cannot take part
- psychotic depression, clinically significant bipolar disorder
- contraindication for performing brain fMRI (metal in the body etc)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Finland
- Helsinki University Central HospitalHelsinki, FinlandContact: Hanna T Harno, MD, PhDTaking people
- Helsinki University Hospital, Department of NeurologyHelsinki, FinlandContact: Hanna Harno, PhDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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.
The 2 groups in the trial
- High ISITreatment being tested
Patients that have clinically significant insomnia according to ISI questionnaire (score 15 or more) at baseline.
Treatment: Pregabalin
- Low ISITreatment being tested
Patients with no clinically significant insomnia according to ISI questionnaire (score 14 or less) at baseline.
Treatment: Pregabalin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
- Fit questions
- Built from NCT06155916, who can take part
- Record updated
- 14 March 2025