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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke; Sleep Quality; AcuTENS

Treatments: Device: Acu-TENS; Other: SHP; Device: Sham Acu-TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT05623137

2022ShamayAcu-tens_Stroke

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Acu-TENS+SHP

Experimental group

Description:

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).

Treatment:

Other: SHP

Device: Acu-TENS

Sham Acu-TENS+SHP

Sham Comparator group

Description:

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).

Treatment:

Device: Sham Acu-TENS

Other: SHP