Auriculotherapy on Older People With Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

magneto-auriculotherapy (MAT)

Intervention Type DEVICE

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.

Treatment arm 2

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

Group Type ACTIVE_COMPARATOR

Laser auriculotherapy (LAT)

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

magneto-auriculotherapy (MAT)

Intervention Type DEVICE

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.

Laser auriculotherapy (LAT)

Intervention Type DEVICE

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

Interventions

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magneto-auriculotherapy (MAT)

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.

Intervention Type DEVICE

Laser auriculotherapy (LAT)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes