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Sleep structure in neuropathic pain patients, psychological factors, brain connectivity, and the effect of pregabalin on sleep and pain

Phase 4
Not yet recruiting
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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, Finland
Hanna Harno
Site contact
+358503427375
hanna.harno@hus.fi
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