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

Primary Purpose

Benign Paroxysmal Positional Vertigo, BPPV

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

The Epley Maneuver

The 360 Degree Maneuver

Mechanical rotational chair

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV chair, Mechanical Rotational Chair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

the Epley Maneuver

the 360 Maneuver

Arm Description

Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.

Treatment of BPPV with the 360 Maneuver in the TRV chair.

Outcomes

Primary Outcome Measures

Treatment success after first treatment

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

Number of treatments

Number of treatment necessary to achieve resolution of vertigo and nystagmus

Secondary Outcome Measures

Dizziness Handicap Inventory (DHI) Questionnaire

Comparison of pre-treatment score and post-treatment score

Adverse events

Registration of adverse events

Recurrence rate

Recurrence of BPPV 3 and 6 months after successful treatment.

Full Information

NCT ID

NCT05834452

First Posted

April 17, 2023

Last Updated

April 26, 2023

Sponsor

Aalborg University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05834452

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

April 1, 2025 (Anticipated)

Study Completion Date

August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Paroxysmal Positional Vertigo, BPPV

Keywords

Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV chair, Mechanical Rotational Chair

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the Epley Maneuver

Arm Type

Active Comparator

Arm Description

Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.

Arm Title

the 360 Maneuver

Arm Type

Active Comparator

Arm Description

Treatment of BPPV with the 360 Maneuver in the TRV chair.

Intervention Type

Procedure

Intervention Name(s)

The Epley Maneuver

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

The 360 Degree Maneuver

Intervention Description

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°).

Intervention Type

Device

Intervention Name(s)

Mechanical rotational chair

Intervention Description

TRV chair

Primary Outcome Measure Information:

Title

Treatment success after first treatment

Description

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

Time Frame

2 year

Title

Number of treatments

Description

Number of treatment necessary to achieve resolution of vertigo and nystagmus

Time Frame

2 year

Secondary Outcome Measure Information:

Title

Dizziness Handicap Inventory (DHI) Questionnaire

Description

Comparison of pre-treatment score and post-treatment score

Time Frame

2 year

Title

Adverse events

Description

Registration of adverse events

Time Frame

2 year

Title

Recurrence rate

Description

Recurrence of BPPV 3 and 6 months after successful treatment.

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Malene Hentze Hansen, MD

Phone

0045 31151838

m.hentze@rn.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Malene Hentze Hansen, MD

Organizational Affiliation

Department of Otolaryngology, Head & Neck Surgery and Audiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Aalborg

State/Province

North Denmark Region

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Malene Hentze Hansen, MD

First Name & Middle Initial & Last Name & Degree

Malene Hentze Hansen, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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