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

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834452
• Other study ID #: 20220060
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2024
• Source: Aalborg University Hospital
• Contact: Malene Hentze Hansen, MD
• Phone: 0045 31151838
• Email: m.hentze[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• BPPV
• Dizziness
• Vertigo

Intervention

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.
• 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

Locations

Country	Name	City	State
Denmark	epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital	Aalborg	North Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success after first treatment	Number of subjects achieving resolution of vertigo and nystagmus after one treatment	2 year
Primary	Number of treatments	Number of treatment necessary to achieve resolution of vertigo and nystagmus	2 year
Secondary	Dizziness Handicap Inventory (DHI) Questionnaire	Comparison of pre-treatment score and post-treatment score	2 year
Secondary	Adverse events	Registration of adverse events	2 year
Secondary	Recurrence rate	Recurrence of BPPV 3 and 6 months after successful treatment.	2 year