Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-99
SponsorSalem Anaesthesia Pain Clinic
About this trial
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
This trial accepts healthy volunteersQualifiers
adult chronic pain patients
good treatment compliance
severe chronic insomnia
failure of non-pharmacologic sleep therapy
Disqualifiers
obstructive sleep apnoea
body mass index (BMI) ≥40
organ insufficiency
cognitive disorder
Trial population
Adult chronic pain clinic patients who have severe chronic insomnia; and undergoing medication treatment for insomnia.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Lemborexant
DrugFor insomnia treatment, each patient ingests Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Sleep quality score, objective measurement using the validated Likert sleep scale
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
Time frame
3 weeksSecondary outcomes
1
Pain score, objective measurement using the validated Numeric Pain Rating scale
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
Time frame
3 weeksSponsors and contacts
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Source ClinicalTrials.gov