Acu-TENS and Acupressure on the Sleep Quality

NCT05410288 | Completed

• 1 other identifier: 2022ShamayAcu-tens
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

acuTENS; Sleep Quality; Insomnia; Acupressure

Outcome Measures

Primary Outcomes (18)

• Pittsburgh sleep quality index (PSQI)

  The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.

  T0, baseline

• Pittsburgh sleep quality index (PSQI)

  The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.

  T1, post (4th week)

• Pittsburgh sleep quality index (PSQI)

  The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.

  T2, follow-up(6th week)

• Insomnia severity index (ISI)

  The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.

  T0, baseline

• Insomnia severity index (ISI)

  The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.

  T1, post (4th week)

• Insomnia severity index (ISI)

  The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.

  T2, follow-up(6th week)

• Total sleep time

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T0, baseline

• Total sleep time

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T1, post (4th week)

• Total sleep time

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T2, follow-up(6th week)

• Sleep efficiency

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T0, baseline

• Sleep efficiency

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T1, post (4th week)

• Sleep efficiency

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T2, follow-up(6th week)

• Sleep onset latency

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T1, post (4th week)

• Sleep onset latency

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T0, baseline

• Sleep onset latency

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T2, follow-up(6th week)

• Time awake after sleep onset

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T1, post (4th week)

• Time awake after sleep onset

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T0, baseline

• Time awake after sleep onset

  Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.

  T2, follow-up(6th week)

Secondary Outcomes (12)

• Heart Rate Variability (HRV)

  T0, baseline

• Heart Rate Variability (HRV)

  T1, post (4th week)

• Heart Rate Variability (HRV)

  T2, follow-up(6th week)

• Depression Anxiety Stress Scale

  T0, baseline

• Depression Anxiety Stress Scale

  T1, post (4th week)

Study Arms (3)

Acu-TENS+SHP

EXPERIMENTAL

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.

Device: Acu-TENS; Other: sleep hygiene program(SHP)

acupressure+SHP

EXPERIMENTAL

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

Other: acupressure+SHP; Other: sleep hygiene program(SHP)

placebo stimulation+SHP

PLACEBO COMPARATOR

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

Other: placebo stimulation+SHP; Other: sleep hygiene program(SHP)

Interventions

Acu-TENS DEVICE

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.

Acu-TENS+SHP

acupressure+SHP OTHER

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.

acupressure+SHP

placebo stimulation+SHP OTHER

Participants in the placebo stimulation + SHP group will receive 30-minute placebo stimulation from identical-looking TENS devices with the electrical circuit disconnected inside.

placebo stimulation+SHP

sleep hygiene program(SHP) OTHER

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.

Acu-TENS+SHP; acupressure+SHP; placebo stimulation+SHP

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To maintain assessor blinding, all interventions will be delivered by the part-time research assistant with health-related education background. All assessments and data entry will be performed by an independent full-time research assistant. In addition, the treatment and assessment will be conducted at different sites. Any analysts or statisticians involved in data management will also be blinded to the identification of each treatment group until the final efficacy analysis for each treatment group has been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Head(RS), ADoRCMI & Professor

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 8, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)