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

Chronic Pain Clinical Trial

Official title:
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

Clinical Trial 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.

Clinical Trial Description

Objectives: Chronic pain is usually associated with insomnia. The objective of this clinical study is to compare the safety and efficacy of Lemborexant or Zopiclone or Clonidine; for the management of chronic insomnia in patients with chronic pain. Methods: 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. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05618002
Study type Observational
Source Salem Anaesthesia Pain Clinic
Contact Olu Bamgbade, MD,FRCPC
Phone +17786286600
Email salem.painclinic@gmail.com
Status Recruiting
Phase
Start date November 8, 2022
Completion date December 31, 2023
View Details
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