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Clinical Trials in Canada / NCT05618002
Recruiting Observational

Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

NCT05618002 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2022-11-08
Last updated
2025-01-27

Condition(s) studied

Chronic InsomniaChronic Pain

Investigational drug(s) / intervention(s)

Lemborexant →

Lemborexant: For insomnia treatment, each patient ingests Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data.

Study summary

Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.

Eligibility

Sex
ALL
Min age
20 Years
Max age
99 Years
Healthy volunteers
Accepted
Inclusion Criteria: * adult chronic pain patients * good treatment compliance * severe chronic insomnia * failure of non-pharmacologic sleep therapy * regular zopiclone therapy for 3 months or more * regular sleep diary * regular pain diary * informed consent for diary review * consent for clinical record quality assurance review Exclusion Criteria: * obstructive sleep apnoea * body mass index (BMI) ≥40 * organ insufficiency * cognitive disorder * inability to provide consent * major neuropsychiatric disorder * unreliable diary * cannabis use * regular alcohol intake * stimulant use * substance abuse * poor treatment compliance * high dose opioid * gabapentinoid use * sedative use * mild insomina * irregular zopiclone intake * regular zopiclone therapy for less than 3 months * previous adverse/allergic reactions to clonidine or zopiclone

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Salem Anaesthesia Pain Clinic Surrey British Columbia Recruiting

More Salem Anaesthesia Pain Clinic trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05618002 on ClinicalTrials.gov ↗ ← All trials in Canada