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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: AcuTENS, Sleep Quality, Stroke

In brief

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.

Key facts

Study ID

NCT05623137

Run by

The Hong Kong Polytechnic University

People needed

70

Starts

2022-12-01

Expected to finish

2025-03-01

Last updated by the study team

2024-10-03

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Hongkong Polytechnic University — Hong Kong, Hong Kong (enrolling)
• The Hong Kong Polytechnic University — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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