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

A

Aalborg University Hospital

Status

Enrolling

Conditions

Benign Paroxysmal Positional Vertigo
BPPV

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05834452
20220060

Details and patient eligibility

About

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).

Full 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.

Enrollment

128 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

the Epley Maneuver
Active Comparator group
Description:
Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.
Treatment:
Device: Mechanical rotational chair
Procedure: The Epley Maneuver
the 360 Maneuver
Active Comparator group
Description:
Treatment of BPPV with the 360 Maneuver in the TRV chair.
Treatment:
Procedure: The 360 Degree Maneuver
Device: Mechanical rotational chair

Trial contacts and locations

1

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Central trial contact

Malene Hentze Hansen, MD

Data sourced from clinicaltrials.gov

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