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

NCT05618002 | Recruiting DMC

• 1 other identifier: SalemAnaesth2022 LemborexZop
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia; Chronic Pain

Keywords

Sedative; Hypnotic

Outcome Measures

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

  3 weeks

Secondary Outcomes (1)

• Pain score, objective measurement using the validated Numeric Pain Rating scale

  3 weeks

Interventions

Lemborexant DRUG

For insomnia treatment, each patient ingests Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data.

Also known as: Zopiclone, Clonidine

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult chronic pain clinic patients who have severe chronic insomnia; and undergoing medication treatment for insomnia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salem Anaesthesia Pain Clinic: lead

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

RECRUITING

Related Publications (1)

• Bamgbade OA, Tai-Osagbemi J, Bamgbade DO, Murphy-Akpieyi O, Fadire A, Soni NK, Mumporeze L. Clonidine is better than zopiclone for insomnia treatment in chronic pain patients. J Clin Sleep Med. 2022 Jun 1;18(6):1565-1571. doi: 10.5664/jcsm.9930.

  PMID: 35112665 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Pain

Interventions

lemborexant; zopiclone; Clonidine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Olu Bamgbade, MD,FRCPC

  Salem Anaesthesia Pain Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olu Bamgbade, MD,FRCPC

CONTACT

+17786286600; salem.painclinic@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: November 8, 2022
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)