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Active, not recruitingNCT05834452Updated Oct 2, 2025

Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair.

An interventional study of The Epley Maneuver and The 360 Degree Maneuver in Benign Paroxysmal Positional Vertigo and BPPV, sponsored by Aalborg University Hospital. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Benign Paroxysmal Positional Vertigo
  • BPPV

Keywords

  • Benign Paroxysmal Positional Vertigo
  • Vertigo
  • Dizziness
  • Vestibular Diseases
  • Epley Maneuver
  • TRV chair
  • Mechanical Rotational Chair
03

In context

Benign Paroxysmal Positional Vertigo

73 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.

This study's planned enrollment of 128 is above the median of 75 across 59 interventional studies indexed under Benign Paroxysmal Positional Vertigo.

Browse Benign Paroxysmal Positional Vertigo studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age above 18 years
  • Confirmed unilateral p-BPPV (canalithiasis and cupulolithiasis)
  • Understand written and spoken Danish

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Active comparator
    the Epley Maneuver

    Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.

    Procedure: The Epley Maneuver · Device: Mechanical rotational chair

  • Active comparator
    the 360 Maneuver

    Treatment of BPPV with the 360 Maneuver in the TRV chair.

    Procedure: The 360 Degree Maneuver · Device: Mechanical rotational chair

Interventions

  • ProcedureThe Epley Maneuver

    5 step procedure where the patient: 1. Sits upright in a neutral position 2. Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis 3. Rotated 90° towards the unaffected side around the yaw axis 4. Rotate a further 90° toward the unaffected side around the yaw axis 5. Rotates back to an upright position with a 135° backward rotation around the pitch axis.

  • ProcedureThe 360 Degree Maneuver

    5 step procedure where the patient: 1. Sits upright in a neutral position 2. Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis 3. Rotate a further 90° backward around the pitch axis (total 225°) 4. Rotate a further 90° backward around the pitch axis (total 315°) 5. Rotate back to an upright position with an additional 45° backward rota-tion around the pitch axis (total 360°).

  • DeviceMechanical rotational chair

    TRV chair

06

What researchers measure

Primary outcomes

  1. Treatment success after first treatment

    Number of subjects achieving resolution of vertigo and nystagmus after one treatment

    Time frame: 2 year

  2. Number of treatments

    Number of treatment necessary to achieve resolution of vertigo and nystagmus

    Time frame: 2 year

Secondary outcomes

  1. Dizziness Handicap Inventory (DHI) Questionnaire

    Comparison of pre-treatment score and post-treatment score

    Time frame: 2 year

  2. Adverse events

    Registration of adverse events

    Time frame: 2 year

  3. Recurrence rate

    Recurrence of BPPV 3 and 6 months after successful treatment.

    Time frame: 2 year

07

Study locations

1 site
  • epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
    Aalborg, North Denmark 9000, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05834452
Lead sponsor
Aalborg University Hospital
Responsible party
Malene Hentze Hansen (medical doctor, Aalborg University Hospital) — Principal investigator
First posted
Apr 28, 2023
Start date
Apr 12, 2023
Primary completion
Oct 31, 2025 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Oct 2, 2025

Study contacts

Malene Hentze Hansen, MD
principal investigator · Department of Otolaryngology, Head & Neck Surgery and Audiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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