Clinical trial
Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain
Name
TYH2020214
Description
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.
Trial arms
Trial start
2022-11-22
Estimated PCD
2025-12-01
Trial end
2026-12-01
Status
Recruiting
Treatment
Pregabalin
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.
Arms:
High ISI, Low ISI
Other names:
Pregabalin for high insomnia patients with painful neuropathy, Pregabalin for low insomnia patients with painful neuropathy
Size
40
Primary endpoint
Pregabalin response to pain
Change from baseline pain intensity and interference immediately after the intervention
Pregabalin effect on sleep stages
Change from baseline immediately after the intervention
Sleep disturbance associations to brain network connectivity
Change from baseline immediately after the intervention
Sleep disturbance associations to choroid plexus volume in brain fMRI
Change from baseline immediately after the intervention
Pregabalin effect on circadian rhythms
Change from baseline immediately after the intervention
Pregabalin effect on body temperature during sleep
Change from baseline immediately after the intervention
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-12-05
1 organization
1 product
3 indications
Organization
Helsinki University Central HospitalProduct
PregabalinIndication
Neuropathic PainIndication
InsomniaIndication
Sleep Disorder