Lemborexant vs Zopiclone vs Clonidine for Insomnia
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
Recruiting
Observational Study
Chronic InsomniaChronic Pain
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 99
Sex
Any
Study type
Observational
Participants needed
150 (estimated)
Sponsor
Salem Anaesthesia Pain Clinic · Other
Who this trial is looking for
This trial is looking for adult patients who have chronic pain and severe insomnia. If you join, you'll take different medications on alternate nights and keep a sleep diary for three weeks.
Are You a Good Fit for This Trial?
Must be takingZopiclone
Rules you outBody mass index (BMI) ≥40Obstructive sleep apnoeaCognitive disorderMajor neuropsychiatric disorder
You may be able to join if
I am an adult with chronic pain.
I have severe chronic insomnia.
I have tried non-drug sleep therapy but it didn't work.
I have been using zopiclone for 3 months or more.
I keep a regular sleep diary.
I keep a regular pain diary.
I agree to let researchers review my diary and clinical records.
You may not be able to join if
I have obstructive sleep apnoea.
My body mass index (BMI) is 40 or above.
I have a cognitive disorder.
I cannot provide consent.
I have a major neuropsychiatric disorder.
I do not keep a reliable diary.
I use cannabis.
I regularly drink alcohol.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 effec…
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 Locations
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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…
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
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