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Clinical Trial Summary

Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the improvement of sleep conditions and quality of life on the elders with insomnia.

Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on the improvement of sleep conditions and quality of life in the elderly with insomnia.

Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and exhibit poor sleep conditions are recruited.

Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT. Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined approach (LAT plus MAT).

The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven specific auricular points.

Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.

Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed effect modeling will be conducted as appropriate.

Expected results This study would advance our knowledge the optimum treatment protocol of AT in the improvement of the sleep conditions of the elderly population.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

NCT number NCT02970695
Study type Interventional
Source The Hong Kong Polytechnic University
Contact
Status Completed
Phase N/A
Start date May 2016
Completion date May 2, 2018

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