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Recruiting
NCT05618002
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Conditions: Chronic Insomnia, Chronic Pain, Restless Leg Syndrome (RLS), Substance Abuse, Tremor, Vasomotor Symptoms; Hot Flashes, Tinnitus, Mood Disorders, ADHD With Sleep Onset Insomnia
Sex: All
Ages: 20 Years – 99 Years
Healthy volunteers: No
Enrollment: 250
Sponsor: Salem Anaesthesia Pain Clinic
Location: Salem Anaesthesia Pain Clinic Surrey British Columbia
Summary
Prospective observational crossover study of 250 adults undergoing chronic pain management. For insomnia treatment, patients alternate their usual prescribed sedative versus Lemborexant or Clonidine; on alternate nights. Patients use a validated smartwatch and a validated sleep diary to collect data including mood score, sleep score, sleep duration, and adverse effects. Patients complete the diary for 20-25 days. Pain and mood are measured using numeric rating scales. Sleep score is measured using the Likert sleep scale. Within-patient differences are analyzed. Any change in pain, mood, 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 night sedative therapy for 3 months or more
* regular sleep diary
* regular pain and mood 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
* other sedative use
* mild insomina
* irregular sedative intake
* regular sedative therapy for less than 3 months
* previous adverse/allergic reactions to clonidine or zopiclone
Source: ClinicalTrials.gov (NCT05618002). StuddyBuddy aggregates publicly available trial information.