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

N/AActive Not RecruitingNCT05834452

Aalborg University Hospital128 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Benign Paroxysmal Positional Vertigo BPPV

Interventions

The Epley ManeuverPROCEDURE

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.

The 360 Degree ManeuverPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Aalborg, North Denmark, Denmark

Outcomes

Primary Outcomes

Treatment success after first treatment

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

Time frame: 2 year

Number of treatments

Number of treatment necessary to achieve resolution of vertigo and nystagmus

Time frame: 2 year

Secondary Outcomes

Dizziness Handicap Inventory (DHI) Questionnaire

Comparison of pre-treatment score and post-treatment score

Time frame: 2 year

Adverse events

Registration of adverse events

Time frame: 2 year

Recurrence rate

Recurrence of BPPV 3 and 6 months after successful treatment.

Time frame: 2 year

Data from ClinicalTrials.gov

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