Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV

Not Applicable

Completed

• Conditions: BPPV
• Interventions: Procedure: Epley's Maneuver; Procedure: Semont Maneuver; Procedure: 360 degree vertical rotation

• Registration Number: NCT04147156
• Lead Sponsor: Aalborg University Hospital

Brief Summary

A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.

Detailed Description

Open-label, randomized controlled trial comparing three different treatment maneuvers in a mechanical rotational chair (ROTUNDUM-chair) in treating BPPV. Patients diagnosed with BPPV will be randomized to one of three maneuvers in the ROTUNDUM-chair:

1. Epley's maneuver

2. Semont maneuver

3. 360 degree vertical rotation

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Study Start: 2020-02-27
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Characteristic (for BPPV) positional nystagmus
• Positive Dix-Hallpike Test
• Medical history compatible with BPPV

Exclusion Criteria

• Treatment in a mechanical rotational chair within the last 6 months
• Exclusion of BPPV diagnosis
• Lack of treatment cooperation
• Known cerebral aneurism or cerebral hemorrhage
• Treated for BPPV within the past month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epley's Maneuver	Epley's Maneuver	Treatment of posterior canal BPPV with Epley's maneuver in the ROTUNDUM-chair.
Semont Maneuver	Semont Maneuver	Treatment of posterior canal BPPV with the Semont maneuver in the ROTUNDUM-chair.
360 degree vertical rotation	360 degree vertical rotation	Treatment of posterior canal BPPV with a 360 degree vertical rotation in the ROTUNDUM-chair.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI) questionnaire	2 years	Comparison of pre- and post-treatment score, total score between 0 and 100. Higher score reflects worse condition
Value of liberatory nystagmus	2 years	Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success
Adverse events	2 years	Registration of adverse events

Trial Locations

Locations (1)

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