Transcutaneous Electrical Nerve Stimulation (TENS) Over Acupoints (Acu-TENS) for Improving Sleep Quality, Cognitive Function, Motor Function and in Post-stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Total sleep time
研究概览
简要总结
Post-stroke sleep disorder and motor/cognitive dysfunction are common complications that affect the quality of life of older patients. The proposed study investigates the effects of an acupuncture-like method applied to six bilateral acupoints on sleep quality, motor function and cognition in older adults with chronic stroke. The study will be a single-blind (i.e., only patients will be blinded about the research purpose) randomized controlled trial (i.e., patients receiving the treatment is chosen at random) with a pre-mid-post follow-up design and involve two parallel groups of post-stroke survivors (aged > 55 years) diagnosed with insomnia. Participants will be randomly allocated in a 1:1 radio to two independent groups, i.e., a treatment group or placebo group, namely a transcutaneous electrical nerve stimulation placed on acupoints (Acu-TENS) or a placebo group. The Acu-TENS group will receive a 6-week treatment that includes a 30-minute Acu-TENS + sleep hygiene program (SHP) twice a week. The placebo group will receive sham Acu-TENS (i.e., devices with the electrical circuit disconnected) + SHP with the same frequency as the Acu-TENS group. The selected acupoints will be bilateral Hegu (LI4), Quchi (LI11), Neiguan (PC6), Shenmen (HT7) on the arm and Sanyinjiao (SP6) and Zusanli (ST36) on the lower limb. The study's primary outcomes will be sleep quality measured by the device of ActiGraph and the self-report survey. The secondary outcomes will be motor function, measured by physical performance tests, cognition, measured by computer battery, and quality of life, measured by the self-report survey. All outcomes will be measured at the baseline assessment (before the treatment), mid-term assessment (after the three weeks treatment), post-treatment assessment (after the six-week treatment), and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia, improve cognition and motor function in participants than the sham Acu-TENS + SHP treatment.
详细描述
The proposed study investigates the effects of non-invasive acupuncture techniques (i.e. transcutaneous electrical nerve stimulation at acupoints; Acu-TENS) applied to six selected bilateral acupoints on sleep quality, motor function and cognition in older adult participants with chronic stroke. This proposed project aims to investigate the effectiveness of Acu-TENS + sleep hygiene program (SHP), compare with placebo-stimulation +SHP on sleep quality, motor function and cognition, and quality of life of older adults with chronic stroke.
Impact:
- Practical significance: The proposed clinical-based randomized controlled trial will rigorously investigate the effects of Acu-TENS applied to selected acupoints on sleep quality, motor function, cognition, and quality of life in older adults with chronic stroke. The results of this study will shed light on the effectiveness of this non-invasive acupuncture treatment for treating insomnia and improving motor and cognition function in older adults with chronic stroke. This will help healthcare professionals treat this highly prevalent disorder for which effective treatments are currently lacking.
- Scientific significance: The proposed study will be the first to investigate the effects of Acu-TENS on elderly patients with post-stroke insomnia. The objective measures used in the rigorously designed study will generate high-quality data and produce rigorous results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Due to the nature of the treatments, only the participants will be blinded to the objectives of the study.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 55 and 85 yrs;
- •diagnosed with stroke by magnetic resonance imaging or computed tomographic scan longer than one year;
- •able to walk 6-m independently;
- •scored ≥18 but less or equal than 27 in mini-mental state examination (MMSE);
- •self-reported poor sleep quality (PSQI, scores ≥ 6) in the past four weeks.
排除标准
- •have a cardiac pacemaker;
- •have a severe disease that precludes the receipt of Acu-TENS;
- •are taking medication that may affect measured outcomes;
- •have skin lesions, infection, or inflammation near selected acupoints;
- •are participating in other drug/treatment programs.
结局指标
主要结局
Total sleep time
时间窗: T3, follow-up(6th week)
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, T2, T3). The validity of this assessment was confirmed in previous research.
Sleep efficiency
时间窗: T3, follow-up(6th week)
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, T2, T3). The validity of this assessment was confirmed in previous research.
Insomnia severity index (ISI)
时间窗: T3, follow-up(6th week)
The subjective perception of the severity of insomnia will be assessed by Insomnia severity index. 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.
Pittsburgh sleep quality index (PSQI)
时间窗: T3, follow-up(6th week)
The subjective sleep quality will be assessed by the Pittsburgh sleep quality index. 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.
Sleep onset latency
时间窗: T3, follow-up(6th week)
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, T2, T3). The validity of this assessment was confirmed in previous research.
Time awake after sleep onset
时间窗: T3, follow-up(6th week)
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, T2, T3). The validity of this assessment was confirmed in previous research.
次要结局
- The Ratio of deformation and Relaxation time(T3, follow-up (6th week))
- Stroop Color and Word Test(T3, follow-up(6th week))
- Depression Anxiety Stress Scale(T3, follow-up (6th week))
- Dynamic Stiffness(T3, follow-up (6th week))
- Trail making test(T3, follow-up (6th week))
- 10-m walk test(T3, follow-up (6th week))
- Lower limb muscle strength(T3, follow-up (6th week))
- Natural Oscillation Frequency(T3, follow-up (6th week))
- Time up and go test(T3, follow-up (6th week))
- The Fatigue Assessment Scale(T3, follow-up (6th week))
- Mechanical Stress Relaxation Time(T3, follow-up (6th week))
- Health-related Quality of Life(T3, follow-up (6th week))
- Logarithmic Decrement of natural oscillation(T3, follow-up (6th week))
研究者
Shamay Ng
Professor
The Hong Kong Polytechnic University