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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 27, 2025 (before its estimated December 11, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: May 11, 2024 to Dec 11, 2025
    • Trial status: Completed to Recruiting
    • Site details revised
    v8
  2. Trial status: Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 31, 2023 to May 11, 2024
    • Site details revised
    v7
  3. Primary completion date: Oct 5, 2023 to Dec 31, 2023
    • Study completion date: Oct 6, 2023 to Dec 31, 2023
    v6
  4. Primary completion date: Apr 5, 2023 to Oct 5, 2023
    • Trial status: Completed to Recruiting
    • Study completion date: Apr 6, 2023 to Oct 6, 2023
    • Site details revised
    v5
  5. Primary completion date: Mar 31, 2023 to Apr 5, 2023v4
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  1. Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Dec 31, 2022 to Mar 31, 2023
    • Study completion date changed from estimate of Dec 31, 2022 to Apr 6, 2023
    • Site details revised
    v3
  2. Primary endpoint revised
    • Secondary endpoint revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05618002
Lead Sponsor Salem Anaesthesia Pain Clinic
Conditions
(from sponsor)		 Chronic Insomnia, Chronic Pain
Related terms Chronic Pain, Sleep Initiation and Maintenance Disorders
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov