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Active, Not Recruiting

NCT Number: NCT05834452

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Benign Paroxysmal Positional Vertigo BPPV Dizziness Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Epley Maneuver

Procedure

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 Maneuver

Procedure

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 chair

Device

TRV chair

Primary outcomes

  1. Treatment success after first treatment

    Time frame: 2 year

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

  2. Number of treatments

    Time frame: 2 year

    Number of treatment necessary to achieve resolution of vertigo and nystagmus

Secondary outcomes

  1. Dizziness Handicap Inventory (DHI) Questionnaire

    Time frame: 2 year

    Comparison of pre-treatment score and post-treatment score

  2. Adverse events

    Time frame: 2 year

    Registration of adverse events

  3. Recurrence rate

    Time frame: 2 year

    Recurrence of BPPV 3 and 6 months after successful treatment.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair: A Randomized Controlled Trial Comparing Epley and 360° Maneuvers.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 28, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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