Clinical trial NCT05410288: Acu-TENS and Acupressure on the Sleep Quality
Official title: A Clinical Investigation of the Effects of Acu-TENS and Acupressure on the Sleep Quality of Older Adults With Insomnia: A Pilot Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: acuTENS
Sleep Quality
Insomnia
Acupressure
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: T0, baseline
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: T1, post (4th week)
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: T2, follow-up(6th week)
measure: Insomnia severity index (ISI)
timeFrame: T0, baseline
measure: Insomnia severity index (ISI)
timeFrame: T1, post (4th week)
measure: Insomnia severity index (ISI)
timeFrame: T2, follow-up(6th week)
measure: Total sleep time
timeFrame: T0, baseline
measure: Total sleep time
timeFrame: T1, post (4th week)
measure: Total sleep time
timeFrame: T2, follow-up(6th week)
measure: Sleep efficiency
timeFrame: T0, baseline
measure: Sleep efficiency
timeFrame: T1, post (4th week)
measure: Sleep efficiency
timeFrame: T2, follow-up(6th week)
measure: Sleep onset latency
timeFrame: T1, post (4th week)
measure: Sleep onset latency
timeFrame: T0, baseline
measure: Sleep onset latency
timeFrame: T2, follow-up(6th week)
measure: Time awake after sleep onset
timeFrame: T1, post (4th week)
measure: Time awake after sleep onset
timeFrame: T0, baseline
measure: Time awake after sleep onset
timeFrame: T2, follow-up(6th week)
Secondary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: T0, baseline
measure: Heart Rate Variability (HRV)
timeFrame: T1, post (4th week)
measure: Heart Rate Variability (HRV)
timeFrame: T2, follow-up(6th week)
measure: Depression Anxiety Stress Scale
timeFrame: T0, baseline
measure: Depression Anxiety Stress Scale
timeFrame: T1, post (4th week)
measure: Depression Anxiety Stress Scale
timeFrame: T2, follow-up(6th week)
measure: The Fatigue Assessment Scale
timeFrame: T0, baseline
measure: The Fatigue Assessment Scale
timeFrame: T1, post (4th week)
measure: The Fatigue Assessment Scale
timeFrame: T2, follow-up(6th week)
measure: Health-related Quality of Life (QoL)
timeFrame: T0, baseline
measure: Health-related Quality of Life (QoL)
timeFrame: T1, post (4th week)
measure: Health-related Quality of Life (QoL)
timeFrame: T2, follow-up(6th week)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
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