Sleep structure in neuropathic pain patients, psychological factors, brain connectivity, and the effect of pregabalin on sleep and pain
- Conditions
- Patients have peristent peripheral neuropathic pain. They are not rare diseases.
- Registration Number
- 2024-515820-35-02
- Lead Sponsor
- HUS-Yhtymae
- Brief Summary
To analyse sleep and its microstructure in neuropathic pain patients who have or who do not have a major sleep disturbance, before and during treatment with pregabalin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 40
Patients with peripheral painful neuropathy, age 18-75 years, pain is chronic (duration >3 months) and moderate to severe intensity (NRS ≥ 4/10) aiming to recruit 20 patients with at least a moderate sleep disturbance as assessed with ISI-questionnaire (>14) and 20 patients without sleep disturbance.
Excessive alcohol consumption (>7 doses/week). If the patient uses gabapentinoids (gabapentin or pregabalin), they are discontinued 2 weeks before the study. Psychotic depression, clinically significant bipolar disorder. Contraindications to brain fMRI.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pregabalin response to pain. Pain intensity and interference assessed by numeric rating scale Pregabalin response to pain. Pain intensity and interference assessed by numeric rating scale
- Secondary Outcome Measures
Name Time Method Pregabalin effect on sleep stages. 1-night Ambulatory Polysomnography (NREM stage III). Pregabalin effect on sleep stages. 1-night Ambulatory Polysomnography (NREM stage III).
Sleep disturbance associations to brain network connectivity. Brain fMRI for brain network connectivity Sleep disturbance associations to brain network connectivity. Brain fMRI for brain network connectivity
Sleep disturbance associations to choroid plexus volume in brain fMRI. Brain fMRI for choroid plexus volume measures Sleep disturbance associations to choroid plexus volume in brain fMRI. Brain fMRI for choroid plexus volume measures
Pregabalin effect on circadian rhythms. 1-week actigraphy and OURA-ring Pregabalin effect on circadian rhythms. 1-week actigraphy and OURA-ring
Pregabalin effect on body temperature during sleep. 1-night body temperature measurement by iButton Pregabalin effect on body temperature during sleep. 1-night body temperature measurement by iButton
Trial Locations
- Locations (1)
HUS-Yhtymae
🇫🇮Helsinki, Finland
HUS-Yhtymae🇫🇮Helsinki, FinlandHanna HarnoSite contact+358503427375hanna.harno@hus.fi