Positional NystagmusNCT05554770
Prevalence of Positional Nystagmus in a Population of Healthy Adults
An observational study of Positional Nystagmus and Healthy Volunteers, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
To investigate the prevalence of positional nystagmus in a population of healthy Danish adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Positional Nystagmus, Healthy Volunteers
- What is being tested?
- Examinations in a TRV chair
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Oct 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A population of healthy adults who meets the in- and exclusion criteria.
Who may be able to join
- + 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otolaryngology, Head- and Neck Surgery and Audiology
Aalborg, North Denmark, 9000
About this study
To investigate the prevalence of positional nystagmus in a population of healthy Danish adults.
Read the 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.
- Conditions
- Positional Nystagmus, Healthy Volunteers
- Being tested
- Examinations in a TRV chair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examinations in a TRV chairDiagnostic test
Positional tests (Dix-Hallpike and SRT) traditionally used to diagnose BPPV uwith a TRV chair.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positional nystagmus
Number of subjects presenting with positional nystagmus during specific changes of head positions.
Measured: 2 years
Secondary outcomes (1)
Characteristics of positional nystagmus
Description the characteristics (latency, velocity, duration, direction) of positional nystagmus in healthy subjects.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start6 Oct 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positional NystagmusStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Dupont Hougaard, Aalborg University Hospital
- Investigators
- Dan D Hougaard, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554770
- Sponsor's protocol ID
- N-20220034
- Other IDs
- F2022-081
- Status last verified
- Aug 2023
- First submitted
- 22 Sep 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Positional Nystagmus in a Population of Healthy Adults
- ClinicalTrials.gov ID
- NCT05554770
- Acronym / sponsor ID
- N-20220034
- Conditions
- Positional Nystagmus, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A population of healthy adults who meets the in- and exclusion criteria.
Key inclusion criteria (1 listed)
- + 18 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examinations in a TRV chairPositional tests (Dix-Hallpike and SRT) traditionally used to diagnose BPPV uwith a TRV chair. | Diagnostic test | – |
Primary outcome
Prevalence of positional nystagmus
Time frame: 2 years
Number of subjects presenting with positional nystagmus during specific changes of head positions.
1 secondary outcome
Characteristics of positional nystagmus
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan D Hougaard, MD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Positional Nystagmus and Healthy Volunteers, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of positional nystagmus (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.