Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05623137
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2022-11-07
Brief Title:
Acu-TENS to Improve the Sleep Quality in People with Stroke
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Transcutaneous Electrical Nerve Stimulation TENS Over Acupoints Acu-TENS for Improving Sleep Quality Cognitive Function Motor Function and in Post-stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-stroke sleep disorder and motorcognitive 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 ie only patients will be blinded about the research purpose randomized controlled trial ie 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 11 radio to two independent groups ie 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 ie 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 studys 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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None