The Influence of Oral Vibrational Stimulation on Cognitive Function of Elderly Individuals

NCT ID: NCT02332525

Last Updated: 2015-01-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to investigate the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with non-dementia subjects (cognitive normal, mild cognitive impairment)

Detailed Description

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Evaluating the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with mild cognitive impairment

◇ 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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Mild Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation

Group Type EXPERIMENTAL

Oral Vibrational Stimulation

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A person who has at least 20 natural teeth, including the first molars (including fixed prostheses and implants, excluding removable prostheses)
* A person who has systemic health, including controlled hypertension/hypotension and diabetes patients

Exclusion Criteria

* A person who has medical history of nervous system disease
* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lee, Hyo-Jung

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyo-Jung Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Central Contacts

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Hyo-Jung Lee, DDS, PhD

Role: CONTACT

82-31-787-7547

Shin-young Park, DDS. PhD

Role: CONTACT

82-31-787-2780

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.

Reference Type BACKGROUND
PMID: 21748004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11269726 (View on PubMed)

Other Identifiers

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B-1407-260-006

Identifier Type: -

Identifier Source: org_study_id

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