Acu-TENS and Acupressure on the Sleep Quality

The Hong Kong Polytechnic University

Status

Completed

Conditions

Sleep Quality

Acupressure

acuTENS

Insomnia

Treatments

Other: sleep hygiene program(SHP)

Other: placebo stimulation+SHP

Device: Acu-TENS

Other: acupressure+SHP

Study type

Interventional

Funder types

Other

Identifiers

NCT05410288

2022ShamayAcu-tens

Details and patient eligibility

About

The study aims to investigate the effects of two non-invasive acupuncture methodologies applied to three selected acupoints on the sleep quality of older adults with insomnia.

The investigators invite participants to participate in the study (12 treatments [3 times/week, 4 weeks in total], 3 tests), which will take about 2 months in total. Participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The placebo group will receive a placebo stimulation+ SHP. Each group will have a 4-week treatment comprising thrice-weekly 30-min sessions of treatment.

For Acu-TENS, electrodes will be attached to participants' sleep-related acupoints for 30 minutes. For acupressure, the investigators will guide participants to apply pressure to each sleep-related acupoint for 5 minutes, for a total of 30 minutes. The process of Sham Acu-TENS stimulation will be the same as Acu-TENS, but the instrument model is different. SHP is a training course in which the investigators will guide participants on how to improve participants' sleep quality by adjusting participants' lifestyle. The sleep quality (survey and actigraphy), insomnia index, heart rate variability, level of fatigue (survey), mood (survey) and quality of life (survey) will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). The investigators will give participants a watch to wear for one week during sleep measurement and then please return it. The watch will record participants' sleep data. For the heart rate variability measurement, participants will need to wear a heart rate monitor in the lab for a short period. After the trials, Participants will have the opportunity to know participants' level of sleep quality and some mental conditions (i.e., mood, fatigue, quality of life). Participants may experience mild skin irritation during treatment. If participants feel uncomfortable, please inform the researcher to reduce the irritation to a relatively comfortable level.

Full description

Insomnia is the most common sleep disorder that affects older adults. This proposed study aims to investigate the effects of two acupuncture methodology applied to three selected acupoints on the sleep quality of older adults with insomnia. The study will be a single-blind randomized controlled trial with a pre-post design and involve three parallel groups of older adult participants (aged > 55 years) diagnosed with insomnia. The participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive a 4-week treatment comprising thrice-weekly 30-min sessions of Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The selected acupoints will be bilateral Sanyinjiao (SP6) on the legs and Shenmen (HT7) and Neiguan (PC6) on the wrists. The placebo group will receive a placebo stimulation+ SHP. The primary outcomes of the study will be sleep quality, insomnia index as well as actigraphy. The secondary outcomes will be heart rate variability, level of fatigue, mood, and quality of life. All the outcomes will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia in participants than acupressure + SHP or placebo stimulation + SHP.

Enrollment

76 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

aged 55 years or older; and
self-reported poor sleep quality (PSQI, scores ≥ 6) in the past 4 weeks

Exclusion criteria

an amputation or recent fracture of upper or lower limbs;
a severe disease that precludes the receipt of Acu-TENS or acupressure (e.g., renal impairment; epilepsy; cardiac pace-mark or another electrical or metal implant in participants' body);
taking medication that may affect sleep;
skin lesions, infection, or inflammation near selected acupoints; or
a psychiatrically diagnosed mental disease.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

76 participants in 3 patient groups, including a placebo group

Acu-TENS+SHP

Experimental group

Description:

Participants in the Acu-TENS group will receive Acu-TENS coupled with a sleep hygiene program (SHP). 4 weeks and comprise thrice-weekly 30-min sessions.

Treatment:

Device: Acu-TENS

Other: sleep hygiene program(SHP)

acupressure+SHP

Experimental group

Description:

The acupressure group will receive acupressure and SHP. 4 weeks and comprise thrice-weekly 30-min sessions.

Treatment:

Other: acupressure+SHP

Other: sleep hygiene program(SHP)

placebo stimulation+SHP

Placebo Comparator group