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Completed

NCT Number: NCT05277038

Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients

A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant.

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Key information

Conditions

Insomnia Chronic Chronic Pain Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pain, Chronic 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

About this study

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

Methods: A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant. Data were 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 was 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

Clonidine 0.1mg pill

Drug

Routine prescription for insomnia

Other names: Clonidine 0.1mg tablet

Clonidine 0.2mg pill

Drug

Routine prescription for insomnia

Other names: Clonidine 0.2mg tablet

Zopiclone 3.75mg pill

Drug

Routine prescription for insomnia

Other names: Zopiclone 3.75mg tablet

Zopiclone 7.5mg pill

Drug

Routine prescription for insomnia

Other names: Zopiclone 7.5mg tablet

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

Sponsors and collaborators

Lead sponsor

Salem Anaesthesia Pain Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
Nov 18, 2022

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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