Benign Paroxysmal Positional VertigoNCT05834452
Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair.
A study testing The Epley Maneuver, The 360 Degree Maneuver and Mechanical rotational chair in people with Benign Paroxysmal Positional Vertigo and BPPV, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Comparison of treatment efficacy of Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo, BPPV
- What is being tested?
- The Epley Maneuver, The 360 Degree Maneuver and Mechanical rotational chair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Apr 2023to 30 Apr 2026
- Phase
- Interventional
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
- Confirmed unilateral p-BPPV (canalithiasis and cupulolithiasis)
- Understand written and spoken Danish
Who cannot join
- Pregnancy
- Weight ≥ 150 kg and or Height ≥ 2m
- Not possible to attend follow-up visits
- Insufficient cooperation during diagnostic testing or treatment in the mechanical rotational chair
- Have received treatment for BPPV in a mechanical rotational chair within the last 6 months
- Sedative antihistamines are taken within the past 7 days
- Comorbidities: Heart failure (EF<40), known cerebral aneurysm, cerebrovascular events (<3 months), and dissection disease
- Spontaneous or gaze evoked nystagmus.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
Aalborg, North Denmark, 9000
About this study
Official title: Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair: A Randomized Controlled Trial Comparing Epley and 360° Maneuvers.
Comparison of treatment efficacy of Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV).
Read the detailed description
Open-label, randomized controlled trial comparing the Epley maneuver with the 360 maneuver using the TRV chair in both scenarios. Patients diagnosed with posterior BPPV will be randomized to receive treatment with either the Epley maneuver or the 360 maneuver.
- Conditions
- Benign Paroxysmal Positional Vertigo, BPPV
- Being tested
- The Epley Maneuver, The 360 Degree Maneuver, Mechanical rotational chair
- Keywords
- Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV chair, Mechanical Rotational Chair
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Epley ManeuverProcedure or surgery
5 step procedure where the patient:
- Sits upright in a neutral position
- Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis
- Rotated 90° towards the unaffected side around the yaw axis
- Rotate a further 90° toward the unaffected side around the yaw axis
- Rotates back to an upright position with a 135° backward rotation around the pitch axis.
The 360 Degree ManeuverProcedure or surgery
5 step procedure where the patient:
- Sits upright in a neutral position
- Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis
- Rotate a further 90° backward around the pitch axis (total 225°)
- Rotate a further 90° backward around the pitch axis (total 315°)
- Rotate back to an upright position with an additional 45° backward rota-tion around the pitch axis (total 360°).
Mechanical rotational chairDevice
TRV chair
| Study group | Role | What they receive |
|---|---|---|
| the Epley Maneuver | Active comparator | Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used. Receives: Procedure: The Epley Maneuver; Device: Mechanical rotational chair |
| the 360 Maneuver | Active comparator | Treatment of BPPV with the 360 Maneuver in the TRV chair. Receives: Procedure: The 360 Degree Maneuver; Device: Mechanical rotational chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success after first treatment
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Measured: 2 year
Number of treatments
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Measured: 2 year
Secondary outcomes (3)
Dizziness Handicap Inventory (DHI) Questionnaire
Comparison of pre-treatment score and post-treatment score
Measured: 2 year
Adverse events
Registration of adverse events
Measured: 2 year
Recurrence rate
Recurrence of BPPV 3 and 6 months after successful treatment.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start12 Apr 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Hentze Hansen, Aalborg University Hospital
- Investigators
- Malene Hentze Hansen, MD, Principal investigator, Department of Otolaryngology, Head & Neck Surgery and Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834452
- Sponsor's protocol ID
- 20220060
- Status last verified
- Oct 2025
- First submitted
- 17 Apr 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hentze M, Hougaard DD, Kingma H. Epley maneuver versus 360 degrees maneuver for treatment of posterior canal benign paroxysmal positional vertigo in a mechanical rotation chair: a randomized controlled trial. Front Neurol. 2026 Sep 8;17:1909757. doi: 10.3389/fneur.2026.1909757. eCollection 2026.
PubMed 42781309