NCT05623137 Acu-TENS to Improve the Sleep Quality in People with Stroke
| NCT ID | NCT05623137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | AcuTENS |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2022-12-01 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05623137 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 85 Years, studying AcuTENS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05623137 currently recruiting?
Yes, NCT05623137 is actively recruiting participants. Contact the research team at Shamay.Ng@polyu.edu.hk for enrollment information.
Where is the NCT05623137 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT05623137 clinical trial?
NCT05623137 is sponsored by The Hong Kong Polytechnic University. The trial plans to enroll 70 participants.