Actively Recruiting

Age: 20Years - 99Years
All Genders
Healthy Volunteers
ID05618002

Lemborexant, Zopiclone, and Clonidine for Treating Insomnia in Adults with Chronic Pain

Led by Salem Anaesthesia Pain Clinic · Updated on 2025-01-27

150

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the safety and effectiveness of three medications—Lemborexant, Zopiclone, and Clonidine—for treating chronic insomnia in adults who also suffer from chronic pain. It involves 150 adult patients who are already managing chronic pain and experiencing severe insomnia that has not improved with non-drug sleep therapies. Participants have been regularly using Zopiclone for at least three months before joining the study. During the study, each participant takes prescribed doses of Lemborexant, Zopiclone, or Clonidine on alternating nights over a continuous period of three weeks. They keep a validated sleep diary to record their pain levels, sleep quality, sleep duration, type of sleep medication taken, and any side effects experienced. Pain is assessed using a numeric rating scale, while sleep quality is measured with the Likert sleep scale. Participants are closely monitored through their sleep and pain diaries, which provide detailed daily information. Researchers analyze changes in pain and sleep scores, considering a 2-point change as significant. The primary outcome is the objective sleep quality score measured over three weeks. Safety and adverse effects are also recorded to evaluate the medications' tolerability during the study period.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 use
  • Regular pain diary use
  • Informed consent for diary review
  • Consent for clinical record quality assurance review
Not Eligible

You will not qualify if you...

  • Obstructive sleep apnea
  • Body mass index (BMI) 40 or higher
  • 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 use
  • Gabapentinoid use
  • Sedative use
  • Mild insomnia
  • Irregular Zopiclone intake
  • Regular Zopiclone therapy for less than 3 months
  • Previous adverse or allergic reactions to Clonidine or Zopiclone

AI-Screening

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Trial Site Locations

Total: 1 location

1

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, Canada, V3S 7J1

Actively Recruiting

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Research Team

O

Olu Bamgbade, MD,FRCPC

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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Published Research Related To This Trial