Clinical trial NCT05623137: Acu-TENS to Improve the Sleep Quality in People with Stroke
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) Over Acupoints (Acu-TENS) for Improving Sleep Quality, Cognitive Function, Motor Function and in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AcuTENS
Sleep Quality
Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: T0, baseline
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: T1, mid (2th week)
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: T2, post (4th week)
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: T3, follow-up(6th week)
measure: Total sleep time
timeFrame: T0, baseline
measure: Total sleep time
timeFrame: T2, post (4th week)
measure: Total sleep time
timeFrame: T3, follow-up(6th week)
measure: Sleep efficiency
timeFrame: T0, baseline
measure: Sleep efficiency
timeFrame: T2, post (4th week)
measure: Sleep efficiency
timeFrame: T3, follow-up(6th week)
measure: Sleep onset latency
timeFrame: T0, baseline
measure: Sleep onset latency
timeFrame: T2, post (4th week)
measure: Sleep onset latency
timeFrame: T3, follow-up(6th week)
measure: Time awake after sleep onset
timeFrame: T0, baseline
measure: Time awake after sleep onset
timeFrame: T2, post (4th week)
measure: Time awake after sleep onset
timeFrame: T3, follow-up(6th week)
measure: Insomnia severity index (ISI)
timeFrame: T0, baseline
measure: Insomnia severity index (ISI)
timeFrame: T1, mid (2th week)
measure: Insomnia severity index (ISI)
timeFrame: T2, post (4th week)
measure: Insomnia severity index (ISI)
timeFrame: T3, follow-up(6th week)
Secondary outcomes:
measure: Stroop Color and Word Test
timeFrame: T0, baseline
measure: Stroop Color and Word Test
timeFrame: T1, mid (2th week)
measure: Stroop Color and Word Test
timeFrame: T2, post (4th week)
measure: Stroop Color and Word Test
timeFrame: T3, follow-up(6th week)
measure: Trail making test
timeFrame: T0, baseline
measure: Trail making test
timeFrame: T1, mid (2th week)
measure: Trail making test
timeFrame: T2, post (4th week)
measure: Trail making test
timeFrame: T3, follow-up (6th week)
measure: 10-m walk test
timeFrame: T0, baseline
measure: 10-m walk test
timeFrame: T1, mid (2th week)
measure: 10-m walk test
timeFrame: T2, post (4th week)
measure: 10-m walk test
timeFrame: T3, follow-up (6th week)
measure: Time up and go test
timeFrame: T0, baseline
measure: Time up and go test
timeFrame: T1, mid (2th week)
measure: Time up and go test
timeFrame: T2, post (4th week)
measure: Time up and go test
timeFrame: T3, follow-up (6th week)
measure: Lower limb muscle strength
timeFrame: T0, baseline
measure: Lower limb muscle strength
timeFrame: T1, mid (2th week)
measure: Lower limb muscle strength
timeFrame: T2, post (4th week)
measure: Lower limb muscle strength
timeFrame: T3, follow-up (6th week)
measure: The Fatigue Assessment Scale
timeFrame: T0, baseline
measure: The Fatigue Assessment Scale
timeFrame: T1, mid (2th week)
measure: The Fatigue Assessment Scale
timeFrame: T2, post (4th week)
measure: The Fatigue Assessment Scale
timeFrame: T3, follow-up (6th week)
measure: Depression Anxiety Stress Scale
timeFrame: T0, baseline
measure: Depression Anxiety Stress Scale
timeFrame: T1, mid (2th week)
measure: Depression Anxiety Stress Scale
timeFrame: T2, post (4th week)
measure: Depression Anxiety Stress Scale
timeFrame: T3, follow-up (6th week)
measure: Natural Oscillation Frequency
timeFrame: T0, baseline
measure: Natural Oscillation Frequency
timeFrame: T1, mid (2th week)
measure: Natural Oscillation Frequency
timeFrame: T2, post (4th week)
measure: Natural Oscillation Frequency
timeFrame: T3, follow-up (6th week)
measure: Health-related Quality of Life
timeFrame: T0, baseline
measure: Health-related Quality of Life
timeFrame: T1, mid (2th week)
measure: Health-related Quality of Life
timeFrame: T2, post (4th week)
measure: Health-related Quality of Life
timeFrame: T3, follow-up (6th week)
measure: Dynamic Stiffness
timeFrame: T0, baseline
measure: Dynamic Stiffness
timeFrame: T1, mid (2th week)
measure: Dynamic Stiffness
timeFrame: T2, post (4th week)
measure: Dynamic Stiffness
timeFrame: T3, follow-up (6th week)
measure: Logarithmic Decrement of natural oscillation
timeFrame: T0, baseline
measure: Logarithmic Decrement of natural oscillation
timeFrame: T1, mid (2th week)
measure: Logarithmic Decrement of natural oscillation
timeFrame: T2, post (4th week)
measure: Logarithmic Decrement of natural oscillation
timeFrame: T3, follow-up (6th week)
measure: Mechanical Stress Relaxation Time
timeFrame: T0, baseline
measure: Mechanical Stress Relaxation Time
timeFrame: T1, mid (2th week)
measure: Mechanical Stress Relaxation Time
timeFrame: T2, post (4th week)
measure: Mechanical Stress Relaxation Time
timeFrame: T3, follow-up (6th week)
measure: The Ratio of deformation and Relaxation time
timeFrame: T0, baseline
measure: The Ratio of deformation and Relaxation time
timeFrame: T1, mid (2th week)
measure: The Ratio of deformation and Relaxation time
timeFrame: T2, post (4th week)
measure: The Ratio of deformation and Relaxation time
timeFrame: T3, follow-up (6th week)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
city: Hong Kong
country: Hong Kong
facility: The Hongkong Polytechnic University
Study officials:
References: