Auriculotherapy on Older People With Insomnia

The Hong Kong Polytechnic University

Status: Completed

Conditions: Insomnia

Treatments: Device: magneto-auriculotherapy (MAT); Device: Laser auriculotherapy (LAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02970695

13144061

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 3 patient groups

Treatment arm 1

Active Comparator group

Description:

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.

Treatment:

Device: magneto-auriculotherapy (MAT)

Treatment arm 2

Active Comparator group

Description:

Subjects will receive LAT. A laser device (Pointer Pulse™) will be used in this study.

Treatment:

Device: Laser auriculotherapy (LAT)

Treatment arm 3

Experimental group

Description:

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.

Treatment:

Device: Laser auriculotherapy (LAT)

Device: magneto-auriculotherapy (MAT)