Recruiting

Lemborexant vs. Zopiclone vs. Clonidine

Sponsor:

Salem Anaesthesia Pain Clinic

Code:

NCT05618002

Conditions

Chronic Insomnia

Chronic Pain

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Lemborexant

Study Details

Brief summary:

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

Chronic Insomnia

Chronic Pain

Study ID

NCT05618002

Start date

Nov 8, 2022

Status verified date

Jan, 2025

Completion date

Dec 11, 2025

Anticipated

Primary completion date

Dec 11, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

Lemborexant

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.

Primary outcome measure

  • Sleep quality score, objective measurement using the validated Likert sleep scale [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Locations

Salem Anaesthesia Pain Clinic

Recruiting

Surrey, British Columbia, Canada, V3S 7J1

Contacts

More Information

Sponsor

Salem Anaesthesia Pain Clinic

Last update posted

Jan 27, 2025

Last verified

Jan, 2025

Keywords

  • Sedative
  • Hypnotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salem Anaesthesia Pain Clinic on 2025-01-27.