Prevalence of Positional Nystagmus in a Population of Hea... | NCT05554770

Studies
Prevalence of Positional Nystagmus in a Population of Healthy Adults

NCT05554770

Sponsor

Aalborg University Hospital

Status

Completed

Last Update Posted

Aug 8, 2023Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Positional Nystagmus
Healthy Volunteers

Interventions

Examinations in a TRV chair

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
F2022-081	Registry Identifier	Datatilsynet, Region Nordjylland, Denmark

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2022Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Sep 22, 2022

First Submission Date that Met QC Criteria

Sep 22, 2022

First Posted Date

Sep 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2023

Last Update Posted Date

Aug 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dan Dupont Hougaard, MD, Associate Professor, Aalborg University HospitalPrincipal Investigator

Lead Sponsor

Aalborg University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Examinations in a TRV chair	Diagnostic Test	Positional tests (Dix-Hallpike and SRT) traditionally used to diagnose BPPV uwith a TRV chair.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan D Hougaard, MD	Aalborg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otolaryngology, Head- and Neck Surgery and Audiology		Aalborg	North Denmark	9000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010808	Physical Examination

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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