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

Not Applicable

Recruiting

• Conditions: BPPV; Benign Paroxysmal Positional Vertigo
• Interventions: Procedure: The Epley Maneuver; Procedure: The 360 Degree Maneuver; Device: Mechanical rotational chair

• Registration Number: NCT05834452
• Lead Sponsor: Aalborg University Hospital

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).

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.

Study Timeline

• Study Start: 2023-04-12
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-04-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-04-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the Epley Maneuver	Mechanical rotational chair	Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.
the 360 Maneuver	Mechanical rotational chair	Treatment of BPPV with the 360 Maneuver in the TRV chair.
the Epley Maneuver	The Epley Maneuver	Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.
the 360 Maneuver	The 360 Degree Maneuver	Treatment of BPPV with the 360 Maneuver in the TRV chair.

Primary Outcome Measures

Name	Time	Method
Number of treatments	2 year	Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success after first treatment	2 year	Number of subjects achieving resolution of vertigo and nystagmus after one treatment

Secondary Outcome Measures

Name	Time	Method
Adverse events	2 year	Registration of adverse events
Dizziness Handicap Inventory (DHI) Questionnaire	2 year	Comparison of pre-treatment score and post-treatment score
Recurrence rate	2 year	Recurrence of BPPV 3 and 6 months after successful treatment.

Trial Locations

Locations (1)

epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital; 🇩🇰 Aalborg, North Denmark Region, Denmark