HealVertigo: Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT05897853

Collaborator

(none)

Enrollment

Location

12.2

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires.

Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated.

Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.

Condition or Disease	Intervention/Treatment	Phase
Vertigo Functional Dizziness Bilateral Vestibulopathy

Study Design

Study Type:

Observational

Actual Enrollment :

62 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness in a Real-world Setting, Using PRO and QoL - a Non-interventional, Prospective, Mono-center, Observational Study

Actual Study Start Date :

Nov 29, 2021

Actual Primary Completion Date :

Dec 5, 2022

Actual Study Completion Date :

Dec 5, 2022

Outcome Measures

Primary Outcome Measures

Dizziness handicap inventory [2 months]
Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment. The DHI has a range from 0 to 100, the higher the score the worse.

Secondary Outcome Measures

Quality of life (QoL) [2 months]
Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment
Postural imbalance [2 months]
Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment
Depressive symptoms in functional dizziness [2 months]
Change from baseline in depressive symptoms of functional dizziness patients assessed by PHQ-9 questionnaires after 2±1 months Vertigoheel® treatment. The PHQ-9 has a range from 0 to 27, the higher the score the worse.
Anxiety symptoms in functional dizziness [2 months]
Change from baseline in anxiety symptoms of functional dizziness patients assessed by GAD-7 questionnaires after 2±1 months Vertigoheel® treatment. The GAD-7 has a range from 0 to 21, the higher the score the worse.

Other Outcome Measures

Vestibular function in bilateral vestibulopathy by video head impulse test [2 months]
Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by video head impulse test after 2±1 months Vertigoheel® treatment.
Vestibular function in bilateral vestibulopathy by caloric testing [2 months]
Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by caloric testing after 2±1 months Vertigoheel® treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Treatment with Vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study.
Bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the Bárány Society
Symptoms for > 3 months of moderate to severe intensity according to the dizziness handicap inventory [0 (minimum score) -100 (maximum score)] between 30 to 90 points.
≥18 years of age
Legally competent male or female outpatient.
Signed informed consent.
Not pregnant (as proven by negative pregnancy test in case of woman of childbearing potential before first study drug administration) or breast-feeding.