Physiology of Vestibular Dysfunction and Clinical Implications

Frailty Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383642
• Other study ID #: NA_00035747-70
• Status: Completed
• Start date: July 2010
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a precursor to the frailty phenotype seen in the elderly population. A recent study found that vestibular dysfunction is common in the US population, and that the prevalence of this impairment increases steeply with age. However, it is unknown whether the aging process has global effects on the vestibular end-organ or whether specific structures, e.g. the semicircular canals or the otoliths, are selectively impaired. Moreover, the clinical implications of specific deficits of the vestibular end-organ are unclear. As such, the aims of this proposed research are: 1) to evaluate whether the normative aging process is predominantly associated with dysfunction of the semicircular canals (as measured by caloric and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by vestibular-evoked myogenic potential (VEMP) testing); 2) to determine if there are any characteristic clinical features associated with the subtypes of vestibular dysfunction; and 3) to assess whether dysfunction of the semicircular canals or of the otoliths is associated with a higher risk of frailty and falls. The investigators plan to pursue these aims through a cross-sectional and prospective cohort study of a group of individuals age 70 and above. Vestibular physiologic tests will be administered to all study participants, and test results will be correlated with baseline clinical symptoms and frailty status as well as prospective one-year fall risk. A greater understanding of vestibular physiologic deficits and clinical implications in older individuals can inform the development of rational vestibular rehabilitation strategies that may more effectively mitigate the frailty phenotype and reduce fall risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 95 Years

Eligibility

Inclusion Criteria:

• Participant's age is 70 years and over?

• Participant is willing and able to give informed consent?

Exclusion Criteria:

• Participant has diabetes mellitus

• Participant has blindness, limited neck range of motion or cervical spine instability

Related Conditions & MeSH terms

• Accidental Falls
• Dysfunction of Vestibular System
• Frailty

Intervention

Other:
• No intervention, observational study

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vestibular function		baseline
Secondary	Number of participants who report one or more falls in a one-year follow-up period		one year