The Effect of Pinhole Glasses on Vestibular Electrical Stimulation

NCT05516017 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-10-04

No results posted yet for this study

Summary

Balance is the ability to control and maintain the body's center of gravity within the support area. One of the important causes of imbalance is right or left sided unilateral vestibular hypofunction. Chronic vestibular hypofunction describes the loss of unilateral peripheral vestibular function lasting more than 3 months. VES is an important method for replacing the sensory afferents lost in the sudden onset of unilateral vestibular hypofunction and for the correct processing of information in the balance center. Regarding the mechanism of action of Vestibular Electrical Stimulation (VES), it is suggested that it generally affects the auditory system at various levels.

Study aimed which was planned as a prospective, randomized, single-blind and single-center study, was conducted between 1 September 2022 and 1 July 2023, to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Vertigo Rehabilitation Outpatient Clinic with chronic vestibular hypofunction and the inclusion criteria. It was planned to include at least 100 matching patients. Participants who meet the inclusion criteria will be randomized into two groups by computer program after they are numbered according to the order of application. VES and exercise therapy will be applied by wearing pinhole glasses to 50 participants selected to Group 1 (G1-Experimental group). VES and exercise therapy without wearing pinhole glasses in 50 participants selected in Group 2 (G2-Control group) will be applied. Before and after the treatment, the severity of dizziness due to vestibular hypofunction, their emotional state, functionality and physical state and balance status will be evaluated. Dizziness severity will be evaluated with a visual analog scale, and emotional status, functionality and physical condition will be evaluated with the Dizziness Disability Inventory (DHI). Balance status will be determined by Tandem Gait Test, Timed Up and Go Test and Berg Balance Test. Evaluations will be made before treatment, at 1 month of treatment, and at 3 months of treatment (1 month after the end of treatment) by another study blind to treatment.

With the data provided as a result of the research, it has contributed to both our country and the world literature, besides vestibular electrical stimulation, which can be used in the treatment of vestibular hypofunction, we will draw attention to the effectiveness of the use of pinhole glasses.

Conditions

  • Vertigo, Peripheral

Interventions

DEVICE

Vestibular Electrical Stimulator and Pinhole Glasses

It is applied with a vestibular electrical stimulation device for 20 msec with 2 Hz, 1-4 mA, 1 mA increments. Very high frequencies can cause auditory perceptions such as 0.5 - 20 kHz, should be avoided. The pinhole glasses are made of 2 pieces of opaque black plastic material with a total of 113 holes on each side. The opaque black plastic is 1.7 mm thick, 4.5 cm wide, and 5.5 cm long. The holes in the opaque black material are arranged horizontally in 11 rows from top to bottom. The diameter of each hole is 1.1 mm, the horizontal distance of the holes from each other is 4.5 mm, and the vertical distance is 3.5 mm.

DEVICE

Vestibular Electrical Stimulator

It is applied with a vestibular electrical stimulation device for 20 msec with 2 Hz, 1-4 mA, 1 mA increments. Very high frequencies can cause auditory perceptions such as 0.5 - 20 kHz, should be avoided.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Ayşe Karan, Prof Dr. · Istanbul University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2023-07-15
Completion
2023-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516017 on ClinicalTrials.gov