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OpenTrials
Completed

NCT Number: NCT01383642

Physiology of Vestibular Dysfunction and Clinical Implications

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.

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Key information

Age range

70 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention, observational study

Other

Primary outcomes

  1. vestibular function

    Time frame: baseline

Secondary outcomes

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • University of California, Los Angeles

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2018
First posted
Jun 28, 2011
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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