Actively Recruiting

Age: 20Years - 99Years
All Genders
Healthy Volunteers
NCT05618002

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

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

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.

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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

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