NCT06155916 Sleep and Neuropathic Pain - Intervention Study on Pregabalin
| NCT ID | NCT06155916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-11-22 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Hanna Harno, PhD
STUDY CHAIR
Helsinki University Hospital, Department of Neurology
Frequently Asked Questions
Who can join the NCT06155916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06155916 currently recruiting?
Yes, NCT06155916 is actively recruiting participants. Contact the research team at hanna.harno@hus.fi for enrollment information.
Where is the NCT06155916 trial being conducted?
This trial is being conducted at Helsinki, Finland, Helsinki, Finland.
Who is sponsoring the NCT06155916 clinical trial?
NCT06155916 is sponsored by Helsinki University Central Hospital. The principal investigator is Hanna Harno, PhD at Helsinki University Hospital, Department of Neurology. The trial plans to enroll 40 participants.