Prevalence of Positional Nystagmus in a Population of Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Positional Nystagmus
• Intervention / Treatment: Diagnostic test: Examinations in a TRV chair

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Denmark
  • North Denmark Region
    • Aalborg, North Denmark Region, Denmark, 9000
      • Department of Otolaryngology, Head- and Neck Surgery and Audiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A population of healthy adults who meets the in- and exclusion criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of positional nystagmus	Number of subjects presenting with positional nystagmus during specific changes of head positions.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of positional nystagmus	Description the characteristics (latency, velocity, duration, direction) of positional nystagmus in healthy subjects.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specify current diagnostic criteria for Benign Paroxysmal Positional Vertigo	Expansion and clarification of current diagnostic criteria for BPPV	2 years

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Dan D Hougaard, MD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Nystagmus, Pathologic
• Other Study ID Numbers: N-20220034; F2022-081 (Registry Identifier: Datatilsynet, Region Nordjylland, Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No