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

BPPV Clinical Trial

Official title:

Efficacy of a New Type of Mechanical Rotational Chair (ROTUNDUM) in Treating BPPV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147156
• Other study ID #: ROTDUNDUM1
• Status: Completed
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2022
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BPPV

Intervention

Procedure:
• Epley's Maneuver
Treatment with Epley's Maneuver in the ROTUNDUM-chair
• Semont Maneuver
Treatment with the Semont Maneuver in the ROTUNDUM-chair
• 360 degree vertical rotation
Treatment with 360 degree vertical rotation in the ROTUNDUM-chair

Locations

Country	Name	City	State
Denmark	Department of Otolaryngology, Head & Neck Surgery and Audiology	Aalborg	North Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatments	Number of treatments necessary to achieve resolution of vertigo and nystagmus	2 years
Primary	Treatment success after first treatment	Number of subjects achieving resolution of vertigo and nystagmus after one treatment	2 years
Secondary	Dizziness Handicap Inventory (DHI) questionnaire	Comparison of pre- and post-treatment score, total score between 0 and 100. Higher score reflects worse condition	2 years
Secondary	Adverse events	Registration of adverse events	2 years
Secondary	Value of liberatory nystagmus	Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success	2 years