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NCT Number: NCT05618002

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

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.

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Key information

Conditions

Chronic Insomnia Chronic Pain Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location status: Recruiting

Location contact

Olu Bamgbade, MD,FRCPC

CONTACT

[email protected]

+17786286600

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lemborexant

Drug

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.

Other names: Zopiclone, Clonidine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Olu Bamgbade, MD,FRCPC

CONTACT

[email protected]

+17786286600

Sponsors and collaborators

Lead sponsor

Salem Anaesthesia Pain Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2022
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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