NCT05834452

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

April 17, 2023

Last Update Submit

October 1, 2025

Conditions

Benign Paroxysmal Positional VertigoBPPV

Keywords

Benign Paroxysmal Positional VertigoVertigoDizzinessVestibular DiseasesEpley ManeuverTRV chairMechanical Rotational Chair

Outcome Measures

Primary Outcomes (2)

  • Treatment success after first treatment

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

    2 year

  • Number of treatments

    Number of treatment necessary to achieve resolution of vertigo and nystagmus

    2 year

Secondary Outcomes (3)

  • Dizziness Handicap Inventory (DHI) Questionnaire

    2 year

  • Adverse events

    2 year

  • Recurrence rate

    2 year

Study Arms (2)

the Epley Maneuver

ACTIVE COMPARATOR

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

Procedure: The Epley ManeuverDevice: Mechanical rotational chair

the 360 Maneuver

ACTIVE COMPARATOR

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

Procedure: The 360 Degree ManeuverDevice: Mechanical rotational chair

Interventions

The Epley ManeuverPROCEDURE

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.

the Epley Maneuver
The 360 Degree ManeuverPROCEDURE

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°).

the 360 Maneuver
Mechanical rotational chairDEVICE

TRV chair

the 360 Maneuverthe Epley Maneuver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigoDizzinessVestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Officials

  • Malene Hentze Hansen, MD

    Department of Otolaryngology, Head & Neck Surgery and Audiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 28, 2023

Study Start

April 12, 2023

Primary Completion

October 31, 2025

Study Completion

April 30, 2026

Last Updated

October 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)