Benign Paroxysmal Positional VertigoNCT03541018
Different Treatments With the TRV Reposition Chair
A study testing Type of repositional maneuvre in people with Benign Paroxysmal Positional Vertigo, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Type of repositional maneuvre
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 1 Jan 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years of age
- Medical history compatible with BPPV
- Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.
Who cannot join
- Former treatment with a repositional Chair
- Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otolaryngology, Head & Neck Surgery and Audiology
Aalborg, North Denmark, 9000
About this study
Official title: Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?
To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.
Read the detailed description
Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Type of repositional maneuvre
- Keywords
- TRV Reposition Chair, Epley Maneuvre
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of repositional maneuvreProcedure or surgery
Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV
| Study group | Role | What they receive |
|---|---|---|
| Posterior canalolithiasis | Experimental | Type of repositional maneuvre Receives: Procedure: Type of repositional maneuvre |
| Lateral cupulolithiasis | Experimental | Type of repositional maneuvre Receives: Procedure: Type of repositional maneuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation by VNG Measurements
Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.
Measured: 2 years
Subjective vertigo
A systematic registration of experienced vertigo during each diagnostic procedure will take place.
Measured: 2 years
Secondary outcomes (1)
Dizziness Handicap Inventory (DHI) questionnaire
Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
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 posted30 May 2018
- Study start1 Jan 2018
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional VertigoStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT03541018
- Sponsor's protocol ID
- VEST01
- Status last verified
- Jul 2022
- First submitted
- 4 May 2018
- Last updated
- 29 Jul 2022
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?
- ClinicalTrials.gov ID
- NCT03541018
- Acronym / sponsor ID
- VEST01
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- TRV Reposition Chair, Epley Maneuvre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 30 May 2018 (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 which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.
Detailed description
Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior canalolithiasis | Experimental | Procedure: Type of repositional maneuvreType of repositional maneuvre |
| Lateral cupulolithiasis | Experimental | Procedure: Type of repositional maneuvreType of repositional maneuvre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years of age
- Medical history compatible with BPPV
- Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.
Key exclusion criteria (2 listed)
- Former treatment with a repositional Chair
- Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair
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 |
|---|---|---|
| Type of repositional maneuvrePatients randomized to 2 different repositional maneuvres related to the subtypes of BPPV | Procedure or surgery | Lateral cupulolithiasis, Posterior canalolithiasis |
Primary outcome
Evaluation by VNG Measurements
Time frame: 2 years
Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.
Subjective vertigo
Time frame: 2 years
A systematic registration of experienced vertigo during each diagnostic procedure will take place.
1 secondary outcome
Dizziness Handicap Inventory (DHI) questionnaire
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 29 Jul 2022.
- Individual participant dataSharing planned: No
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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?
A study testing Type of repositional maneuvre in people with Benign Paroxysmal Positional Vertigo, 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 3 inclusion and 2 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 29 Jul 2022. 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?
Evaluation by VNG Measurements (time frame: 2 years). The study lists 2 primary outcomes in all. 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 29 Jul 2022.