Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT02970695
Brief 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.
Study:
NCT02970695
Study Brief:
Protocol Section:
NCT02970695