Clinical trial NCT02970695: Auriculotherapy on Older People With Insomnia
Official title: Effectiveness of Auriculotherapy on Older People With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: insomnia
older people
auriculotherapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 147
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: up to 6-month follow up
Secondary outcomes:
measure: Sleep latency
timeFrame: up to 6-month follow up
measure: Wake after sleep onset
timeFrame: up to 6-month follow up
measure: Total sleep time
timeFrame: up to 6-month follow up
measure: Sleep efficiency
timeFrame: up to 6-month follow up
measure: The Chinese (HK) specific SF-12 v2©
timeFrame: up to 6-month follow up
measure: Patient Health Questionnaire
timeFrame: up to 6-month follow up
measure: Insomnia Severity Index
timeFrame: up to 6-month follow up
Other outcomes:
measure: The 'Subjects' expectation questionnaire'
timeFrame: up to post-intervention at 6 weeks
Locations:
city: Hong Kong
country: Hong Kong
facility: The Neighbourhood Advice-Action Council
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Lorna Suen, BN, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.