Overview

This trial is active, not recruiting.

Conditions dysfunction of vestibular system, accidental falls, frailty
Treatment no intervention, observational study
Sponsor Johns Hopkins University
Collaborator University of California, Los Angeles
Start date July 2010
End date June 2013
Trial size 50 participants
Trial identifier NCT01383642, NA_00035747-70

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 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 their 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
no intervention, observational study

Primary Outcomes

Measure
vestibular function
time frame: baseline

Secondary Outcomes

Measure
Number of participants who report one or more falls in a one-year follow-up period
time frame: one year

Eligibility Criteria

Male or female participants from 70 years up to 95 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.