Study Results
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Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2022-06-01
2023-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Acu-TENS+SHP
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.
Acu-TENS
A TENS stimulator will be used (NeuroTrac TENS; Verity Medical Ltd., Wexford, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral SP6, PC6 and HT7) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter's waveform will be set to 100 Hz and the square pulses will be set to 0.2-ms. The intensity of the stimulation will be below motor threshold and lower than the intolerable level, and hence, participants will feel a pleasant and mild aching sensation.
sleep hygiene program(SHP)
SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.
acupressure+SHP
The acupressure group will receive acupressure and SHP. 4 weeks and comprise thrice-weekly 30-min sessions.
acupressure+SHP
Participants in the acupressure group will receive acupressure coupled with SHP. The acupressure protocol was developed based on a protocol recommended by a review and will comprise the following: (1) applying consistent finger-tip pressure of 3-5 kg, with rotational movements; (2) counterclockwise and then clockwise circular motions for 2.5-min each; (3) confirming the precision of the acupressure based on participants feeling pain, numbness, distension, or warmth at the point of application; and (4) an acupoint sequence from the leg to the head, first on the left side of the body and then on the right side of the body; and (5) a 5-min treatment on each acupoint (i.e., bilateral SP6, PC6, and HT7) in each 30-min session. The SHP is the same with Acu-TENS+SHP group.
sleep hygiene program(SHP)
SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.
placebo stimulation+SHP
The placebo group will receive a placebo stimulation and SHP. 4 weeks and comprise thrice-weekly 30-min sessions.
placebo stimulation+SHP
Participants in the placebo stimulation + SHP group will receive 30-minute placebo stimulation from identical-looking TENS devices with the electrical circuit disconnected inside.
sleep hygiene program(SHP)
SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.
Interventions
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Acu-TENS
A TENS stimulator will be used (NeuroTrac TENS; Verity Medical Ltd., Wexford, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral SP6, PC6 and HT7) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter's waveform will be set to 100 Hz and the square pulses will be set to 0.2-ms. The intensity of the stimulation will be below motor threshold and lower than the intolerable level, and hence, participants will feel a pleasant and mild aching sensation.
acupressure+SHP
Participants in the acupressure group will receive acupressure coupled with SHP. The acupressure protocol was developed based on a protocol recommended by a review and will comprise the following: (1) applying consistent finger-tip pressure of 3-5 kg, with rotational movements; (2) counterclockwise and then clockwise circular motions for 2.5-min each; (3) confirming the precision of the acupressure based on participants feeling pain, numbness, distension, or warmth at the point of application; and (4) an acupoint sequence from the leg to the head, first on the left side of the body and then on the right side of the body; and (5) a 5-min treatment on each acupoint (i.e., bilateral SP6, PC6, and HT7) in each 30-min session. The SHP is the same with Acu-TENS+SHP group.
placebo stimulation+SHP
Participants in the placebo stimulation + SHP group will receive 30-minute placebo stimulation from identical-looking TENS devices with the electrical circuit disconnected inside.
sleep hygiene program(SHP)
SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.
Eligibility Criteria
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Inclusion Criteria
* self-reported poor sleep quality (PSQI, scores ≥ 6) in the past 4 weeks
Exclusion Criteria
* 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.
55 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Shamay Ng
Assoc. Head(RS), ADoRCMI & Professor
Locations
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The Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Countries
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References
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Other Identifiers
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2022ShamayAcu-tens
Identifier Type: -
Identifier Source: org_study_id
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