NCT05618002 Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
| NCT ID | NCT05618002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Salem Anaesthesia Pain Clinic |
| Condition | Chronic Insomnia |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-11-08 |
| Primary Completion | 2025-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-11-08 with a primary completion date of 2025-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Olu Bamgbade, MD,FRCPC
PRINCIPAL INVESTIGATOR
Salem Anaesthesia Pain Clinic
Frequently Asked Questions
Who can join the NCT05618002 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 99 Years, studying Chronic Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05618002 currently recruiting?
Yes, NCT05618002 is actively recruiting participants. Contact the research team at salem.painclinic@gmail.com for enrollment information.
Where is the NCT05618002 trial being conducted?
This trial is being conducted at Surrey, Canada.
Who is sponsoring the NCT05618002 clinical trial?
NCT05618002 is sponsored by Salem Anaesthesia Pain Clinic. The principal investigator is Olu Bamgbade, MD,FRCPC at Salem Anaesthesia Pain Clinic. The trial plans to enroll 150 participants.
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