Insomnia Clinical Trial
Official title:
Effectiveness of Auriculotherapy on Older People With Insomnia
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.
n/a
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