Acu-TENS to Improve the Sleep Quality in People with Stroke

NCT ID: NCT05623137

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-03-01

Brief Summary

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.

Detailed Description

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:

1. 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.

2. 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.

Conditions

AcuTENS; Sleep Quality; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acu-TENS+SHP

The 120z Dual-Channel TENS Unit (ECS300A; Neurotrac, Verity Medical LTD, Ireland) will be used to stimulate the selected acupoints. The electrode will be placed over the acupoints and connected to the TENS stimulator. The stimulation frequency will be set at 100 Hz with a pulse width of 0.2 ms. Participants will also receive a set of instructions relating to SHP. SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. Participants will be instructed to read the guide after the baseline assessment (T0).

Group Type: EXPERIMENTAL

Acu-TENS

Intervention Type: DEVICE

A dual-channel TENS stimulator will be used (ECS300A; Neurotrac, Verity Medical LTD, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) 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.

SHP

Intervention Type: 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.

Sham Acu-TENS+SHP

Participants will receive similar treatment as Acu-TENS groups via identical-looking TENS devices with the electrical circuit disconnected.Participants will also receive a set of instructions relating to SHP. SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. Participants will be instructed to read the guide after the baseline assessment (T0).

Group Type: SHAM_COMPARATOR

Sham Acu-TENS

Intervention Type: DEVICE

A dual-channel TENS stimulator will be used (ITO Physiotherapy \& Rehabilitation, Co, Ltd, Tokyo, Japan). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) 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.

SHP

Intervention Type: 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.

Interventions

Acu-TENS

A dual-channel TENS stimulator will be used (ECS300A; Neurotrac, Verity Medical LTD, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) 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.

Intervention Type: DEVICE

Sham Acu-TENS

A dual-channel TENS stimulator will be used (ITO Physiotherapy \& Rehabilitation, Co, Ltd, Tokyo, Japan). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Shamay Ng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: NOT_YET_RECRUITING

The Hongkong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shamay Ng, PhD

Role: CONTACT

Shamay.Ng@polyu.edu.hk

27664889

Facility Contacts

Shamay Ng, PhD

Role: primary

Shamay.Ng@polyu.edu.hk

27664889

Shamay SM Ng, PhD

Role: backup

Other Identifiers

2022ShamayAcu-tens_Stroke

Identifier Type: -

Identifier Source: org_study_id