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

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

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).

Study Overview

• Status: Recruiting
• Conditions: BPPV; Benign Paroxysmal Positional Vertigo
• Intervention / Treatment: Procedure: The Epley Maneuver; Device: Mechanical rotational chair; Procedure: The 360 Degree Maneuver

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 Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malene Hentze Hansen, MD; Phone Number: 0045 31151838; Email: m.hentze@rn.dk

Study Locations

• Denmark
  • North Denmark Region
    • Aalborg, North Denmark Region, Denmark, 9000
      • Recruiting
      • epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
      • Contact: Malene Hentze Hansen, MD
      • Principal Investigator: Malene Hentze Hansen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the Epley Maneuver; Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used.	Procedure: The Epley Maneuver; 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.; Device: Mechanical rotational chair; TRV chair
Active Comparator: the 360 Maneuver; Treatment of BPPV with the 360 Maneuver in the TRV chair.	Device: Mechanical rotational chair; TRV chair; Procedure: The 360 Degree Maneuver; 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°).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success after first treatment	Number of subjects achieving resolution of vertigo and nystagmus after one treatment	2 year
Number of treatments	Number of treatment necessary to achieve resolution of vertigo and nystagmus	2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Malene Hentze Hansen, MD, Department of Otolaryngology, Head & Neck Surgery and Audiology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Benign Paroxysmal Positional Vertigo; Vertigo; Dizziness; Vestibular Diseases; Epley Maneuver; TRV chair; Mechanical Rotational Chair
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: 20220060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No