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OpenTrials
Completed

NCT Number: NCT05554770

Prevalence of Positional Nystagmus in a Population of Healthy Adults

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Otolaryngology, Head- and Neck Surgery and Audiology

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Examinations in a TRV chair

Diagnostic Test

Positional tests (Dix-Hallpike and SRT) traditionally used to diagnose BPPV uwith a TRV chair.

Primary outcomes

  1. Prevalence of positional nystagmus

    Time frame: 2 years

    Number of subjects presenting with positional nystagmus during specific changes of head positions.

Secondary outcomes

  1. Characteristics of positional nystagmus

    Time frame: 2 years

    Description the characteristics (latency, velocity, duration, direction) of positional nystagmus in healthy subjects.

Other outcomes

  1. Specify current diagnostic criteria for Benign Paroxysmal Positional Vertigo

    Time frame: 2 years

    Expansion and clarification of current diagnostic criteria for BPPV

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2022
Registry last updated
Aug 8, 2023

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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