Auriculotherapy on Older People With Insomnia

NCT02970695 | Completed

• 1 other identifier: 13144061
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

insomnia; older people; auriculotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6-month follow up

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• The 'Subjects' expectation questionnaire'

  up to post-intervention at 6 weeks

Study Arms (3)

Treatment arm 1

ACTIVE COMPARATOR

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.

Device: magneto-auriculotherapy (MAT)

Treatment arm 2

ACTIVE COMPARATOR

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

Device: Laser auriculotherapy (LAT)

Treatment arm 3

EXPERIMENTAL

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.

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

Interventions

magneto-auriculotherapy (MAT) 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 1; Treatment arm 3

Laser auriculotherapy (LAT) 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 2; Treatment arm 3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Neighbourhood Advice-Action Council

Hong Kong, 00000, Hong Kong

Location

Related Publications (1)

• Suen LKP, Molassiotis A, Yueng SKW, Yeh CH. Comparison of Magnetic Auriculotherapy, Laser Auriculotherapy and Their Combination for Treatment of Insomnia in the Elderly: A Double-Blinded Randomised Trial. Evid Based Complement Alternat Med. 2019 May 21;2019:3651268. doi: 10.1155/2019/3651268. eCollection 2019.

  PMID: 31239857 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Lorna Suen, BN, MPH, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: November 22, 2016
• Study Start: May 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: May 2, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)