The Influence of Oral Vibrational Stimulation on Cognitive Function of Elderly Individuals
NCT ID: NCT02332525
Last Updated: 2015-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2015-01-31
2016-12-31
Brief Summary
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Detailed Description
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◇ Test design: Open-labeled, prospective, pre-post study
○ Oral vibratory stimulus: As an optimal algorithm drawn through the first year study, the vibratory stimulus is applied 10 times for 15 days (a 5-minute stimulus is applied two times a day for 10 days, and it is composed of repeated 15-second vibratory and 15-second non-vibratory stimulus with a strength of 3.3V).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation
Oral Vibrational Stimulation
Oral application of vibratory stimulus
: With the oral equipment, which is similar to the device generally used to prevent teeth grinding in dental clinics, 15-second vibratory and 15-second non-vibratory stimulus are given repeatedly for about 5 minutes using a vibrator that has a strength less than or equal to the vibratory stimulus of a smartphone (3.3V, 166Hz, maximum 180Hz). A stimulus of two times for 5 minutes, a total of at least 10 minutes is conducted for 10 days in a hospital or designated place.
Interventions
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Oral Vibrational Stimulation
Oral application of vibratory stimulus
: With the oral equipment, which is similar to the device generally used to prevent teeth grinding in dental clinics, 15-second vibratory and 15-second non-vibratory stimulus are given repeatedly for about 5 minutes using a vibrator that has a strength less than or equal to the vibratory stimulus of a smartphone (3.3V, 166Hz, maximum 180Hz). A stimulus of two times for 5 minutes, a total of at least 10 minutes is conducted for 10 days in a hospital or designated place.
Eligibility Criteria
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Inclusion Criteria
* A person who has systemic health, including controlled hypertension/hypotension and diabetes patients
Exclusion Criteria
* A person who is has ever been allergic to resin
* A person who has untreated periodontal disease and/or severely loose teeth
* A person who has a medical treatment history of temporomandibular disorders, who has an occurrence of stomatitis once or more per month within the last 6 months, or who currently has stomatitis
* A person who is receiving or has received treatment for major mental diseases such as dementia, major depression, or mania based on the DSM-IV diagnosis
* A person who has a medical disease that can have a serious effect on cognitive function or is taking related medicine
* A person who has a transplant that is electrically or mechanically operated or a cerebrovascular clip or who has claustrophobia so that an MRI scan is impossible
50 Years
75 Years
ALL
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Lee, Hyo-Jung
assistant professor
Principal Investigators
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Hyo-Jung Lee
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Central Contacts
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References
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Paganini-Hill A, White SC, Atchison KA. Dental health behaviors, dentition, and mortality in the elderly: the leisure world cohort study. J Aging Res. 2011;2011:156061. doi: 10.4061/2011/156061. Epub 2011 Jun 15.
Shimazaki Y, Soh I, Saito T, Yamashita Y, Koga T, Miyazaki H, Takehara T. Influence of dentition status on physical disability, mental impairment, and mortality in institutionalized elderly people. J Dent Res. 2001 Jan;80(1):340-5. doi: 10.1177/00220345010800010801.
Other Identifiers
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B-1407-260-006
Identifier Type: -
Identifier Source: org_study_id
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