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

Study Timeline

• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

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

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, Finland

Hanna Harno

Site contact

+358503427375

hanna.harno@hus.fi