Effectiveness of Auriculotherapy on Older People With Insomnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- Pittsburgh Sleep Quality Index (PSQI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Volunteers who are aged 65 or above
- •Report having difficulty falling or staying asleep, and/or frequent nocturnal awakenings
- •At least three nights per week, sleep disturbance has lasted for a minimum of six months
- •Their sleep is of poor quality as indicated by a PSQI score greater than five.
Exclusion Criteria
- •profound physical illness, such as stroke
- •diagnosed with obstructive sleep apnoea
- •having a hearing aid or pacemaker in situ (to prevent the magnetic pellets from interfering with the devices)
- •receiving AT within the preceding 6 months,
- •suffering from aural injuries or infections, and
- •inability to understand instructions or give consent.
Arms & Interventions
Treatment arm 1
To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of MAT. The subjects will be asked to wear a pair of laser protective goggles so as to "blind" them during treatment.
Intervention: magneto-auriculotherapy (MAT) (Device)
Treatment arm 2
Subjects will receive LAT. A laser device (Pointer Pulse™) will be used in this study.
Intervention: Laser auriculotherapy (LAT) (Device)
Treatment arm 3
Subjects will receive a combined approach that includes the use of LAT plus MAT. LAT will be administered prior to MAT application on the selected auricular points, and the procedures used will be similar to the procedures described for Group 1 and Group 2.
Intervention: magneto-auriculotherapy (MAT) (Device)
Treatment arm 3
Subjects will receive a combined approach that includes the use of LAT plus MAT. LAT will be administered prior to MAT application on the selected auricular points, and the procedures used will be similar to the procedures described for Group 1 and Group 2.
Intervention: Laser auriculotherapy (LAT) (Device)
Outcomes
Primary Outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: up to 6-month follow up
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.
Secondary Outcomes
- Sleep latency(up to 6-month follow up)
- Wake after sleep onset(up to 6-month follow up)
- Total sleep time(up to 6-month follow up)
- Sleep efficiency(up to 6-month follow up)
- The Chinese (HK) specific SF-12 v2©(up to 6-month follow up)
- Patient Health Questionnaire(up to 6-month follow up)
- Insomnia Severity Index(up to 6-month follow up)
Investigators
Lorna Suen
Associate Professor
The Hong Kong Polytechnic University