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

NCT ID: NCT05834452

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2026-04-30

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.

Conditions

Benign Paroxysmal Positional Vertigo; BPPV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the Epley Maneuver

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

Group Type: ACTIVE_COMPARATOR

The Epley Maneuver

Intervention Type: PROCEDURE

5 step procedure where the patient:

1. Sits upright in a neutral position

2. Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis

3. Rotated 90° towards the unaffected side around the yaw axis

4. Rotate a further 90° toward the unaffected side around the yaw axis

5. Rotates back to an upright position with a 135° backward rotation around the pitch axis.

Mechanical rotational chair

Intervention Type: DEVICE

TRV chair

the 360 Maneuver

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

Group Type: ACTIVE_COMPARATOR

The 360 Degree Maneuver

Intervention Type: PROCEDURE

5 step procedure where the patient:

1. Sits upright in a neutral position

2. Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis

3. Rotate a further 90° backward around the pitch axis (total 225°)

4. Rotate a further 90° backward around the pitch axis (total 315°)

5. Rotate back to an upright position with an additional 45° backward rota-tion around the pitch axis (total 360°).

Mechanical rotational chair

Intervention Type: DEVICE

TRV chair

Interventions

The Epley Maneuver

5 step procedure where the patient:

1. Sits upright in a neutral position

2. Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis

3. Rotated 90° towards the unaffected side around the yaw axis

4. Rotate a further 90° toward the unaffected side around the yaw axis

5. Rotates back to an upright position with a 135° backward rotation around the pitch axis.

Intervention Type: PROCEDURE

The 360 Degree Maneuver

5 step procedure where the patient:

1. Sits upright in a neutral position

2. Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis

3. Rotate a further 90° backward around the pitch axis (total 225°)

4. Rotate a further 90° backward around the pitch axis (total 315°)

5. Rotate back to an upright position with an additional 45° backward rota-tion around the pitch axis (total 360°).

Intervention Type: PROCEDURE

Mechanical rotational chair

TRV chair

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Malene Hentze Hansen

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malene Hentze Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology, Head & Neck Surgery and Audiology

Locations

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

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

20220060

Identifier Type: -

Identifier Source: org_study_id