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Recruiting
NCT05618002
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
Conditions: Chronic Insomnia, Chronic Pain
Sex: All
Ages: 20 Years – 99 Years
Healthy volunteers: 1
Enrollment: 150
Sponsor: Salem Anaesthesia Pain Clinic
Location: Canada
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 Criteria
Inclusion Criteria:adult chronic pain patientsgood treatment compliancesevere chronic insomniafailure of non-pharmacologic sleep therapyregular zopiclone therapy for 3 months or moreregular sleep diaryregular pain diaryinformed consent for diary reviewconsent for clinical record quality assurance reviewExclusion Criteria:obstructive sleep apnoeabody mass index (BMI) ≥40organ insufficiencycognitive disorderinability to provide consentmajor neuropsychiatric disorderunreliable diarycannabis useregular alcohol intakestimulant usesubstance abusepoor treatment compliancehigh dose opioidgabapentinoid usesedative usemild insominairregular zopiclone intakeregular zopiclone therapy for less than 3 monthsprevious adverse/allergic reactions to clonidine or zopiclone
Source: ClinicalTrials.gov (NCT05618002). StuddyBuddy aggregates publicly available trial information.