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NCT05554770 Clinical Trial

Prevalence of Positional Nystagmus in a Population of Healthy Adults

Healthy Volunteers Clinical Trial

Official title:
Prevalence of Positional Nystagmus in a Population of Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05554770
Other study ID # N-20220034
Secondary ID F2022-081
Status Completed
Phase
First received
Last updated
Start date October 6, 2022
Est. completion date January 1, 2023

Study information
Verified date August 2023
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the prevalence of positional nystagmus in a population of healthy Danish adults.

Description:

Open-label, cross-sectional prospective study examining the prevalence of positional nystagmus in healthy adults (adult with no previous or current inner ear disease) using a mechanical repositioning chair (TRV-chair, Interacoustics, Middelfart, Denmark). Patients will undergo traditional testing related to positional nystagmus by means of both the Dix-Hallpike test and Supine Roll Test (SRT) bilaterally. Latency, duration, and slow phase velocities will be registered and examiner as well as order of the positional tests performed with the TRV chair will be block randomized.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - + 18 years Exclusion Criteria: - Previous or current BPPV, inner ear disease, other ear conditions or neurological conditions - Reduced eye mobility - Alcohol consumption within 48 hours - Weight > 150 kg. - Known cerebral aneurysm - Cerebral haemorrhage within 1 month - Trouble cooperating during examinations - DHI-score > 14

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Examinations in a TRV chair
Positional tests (Dix-Hallpike and SRT) traditionally used to diagnose BPPV uwith a TRV chair.

Locations
Country Name City State
Denmark Department of Otolaryngology, Head- and Neck Surgery and Audiology Aalborg North Denmark Region

Sponsors (1)
Lead Sponsor Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Specify current diagnostic criteria for Benign Paroxysmal Positional Vertigo Expansion and clarification of current diagnostic criteria for BPPV 2 years
Primary Prevalence of positional nystagmus Number of subjects presenting with positional nystagmus during specific changes of head positions. 2 years
Secondary Characteristics of positional nystagmus Description the characteristics (latency, velocity, duration, direction) of positional nystagmus in healthy subjects. 2 years
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