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

January 23, 2025 updated by: Salem Anaesthesia Pain Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives: Chronic pain is usually associated with insomnia. The objective of this clinical study is to compare the safety and efficacy of Lemborexant or Zopiclone or Clonidine; for the management of chronic insomnia in patients with chronic pain.

Methods: 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. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 7J1
        • Recruiting
        • Salem Anaesthesia Pain Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult chronic pain clinic patients who have severe chronic insomnia; and undergoing medication treatment for insomnia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality score, objective measurement using the validated Likert sleep scale
Time Frame: 3 weeks
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score, objective measurement using the validated Numeric Pain Rating scale
Time Frame: 3 weeks
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salem Anaesthesia Pain Clinic

Investigators

  • Principal Investigator: Olu Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Estimated)

December 11, 2025

Study Completion (Estimated)

December 11, 2025

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SalemAnaesth2022 LemborexZop

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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