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

Sponsor

Aalborg University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05834452

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Benign Paroxysmal Positional Vertigo BPPV	Procedure: The Epley Maneuver Procedure: The 360 Degree Maneuver Device: Mechanical rotational chair	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

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.	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°). Device: Mechanical rotational chair TRV chair

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.

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°).

Device: Mechanical rotational chair

TRV chair

Outcome Measures

Primary Outcome Measures

Treatment success after first treatment [2 year]
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Number of treatments [2 year]
Number of treatment necessary to achieve resolution of vertigo and nystagmus

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.