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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
147
Subjects will then receive MAT. The magnetic pellets will have \~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm.The experimental object will be applied to the seven selected acupoints as detected by an acupoint detector. Only one ear will receive treatment at a time, and the pellets will remain in situ for two days before the next change.
A laser device (Pointer Pulse™)15 will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm,2 and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. 16, 17 This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the selected acupoints. Laser protective goggles will be provided to the subjects and the researcher for eyes protection
The Neighbourhood Advice-Action Council
Hong Kong, Hong Kong
Pittsburgh Sleep Quality Index (PSQI)
for collecting data related to the sleep patterns of the subjects. The total score ranges from 0 to 21, with a score greater than five indicating poor sleep quality. Chong and Cheung19 have validated the Cantonese-PSQI and have reported a high internal consistency of 0.75.
Time frame: up to 6-month follow up
Sleep latency
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep latency refers to the length of time it takes from lying down for the night until sleep onset.
Time frame: up to 6-month follow up
Wake after sleep onset
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Wake after sleep onset refers to the amount of time test subjects have spent awake after initially falling asleep and before they awaken for good.
Time frame: up to 6-month follow up
Total sleep time
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Total sleep time refers to the actual sleep time in a sleep episode.
Time frame: up to 6-month follow up
Sleep efficiency
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep efficiency is the ratio of total time spent asleep (total sleep time) in an evening to the total amount of time spent in bed.
Time frame: up to 6-month follow up
The Chinese (HK) specific SF-12 v2©
to evaluate the quality of life of the subjects, and has been found to have positive psychometric properties for use in the local population
Time frame: up to 6-month follow up
Patient Health Questionnaire
to evaluate the depression status
Time frame: up to 6-month follow up
Insomnia Severity Index
to evaluate sleep conditions
Time frame: up to 6-month follow up
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