Physiology of Vestibular Dysfunction and Clinical Implications

NCT01383642 | Completed

• 1 other identifier: NA_00035747-70
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysfunction of Vestibular System; Accidental Falls; Frailty

Outcome Measures

Primary Outcomes (1)

• vestibular function

  baseline

Secondary Outcomes (1)

• Number of participants who report one or more falls in a one-year follow-up period

  one year

Study Arms (1)

individuals age >=70

Other: No intervention, observational study

Interventions

No intervention, observational study OTHER

individuals age >=70

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community-dwelling adults age \>70

You may qualify if:

• Participant's age is 70 years and over?
• Participant is willing and able to give informed consent?

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 28, 2011
• Study Start: July 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

US (1)