Effective Treatments for Dizziness After BPPV: A Clinical Study

NCT06936345 | Completed

• 1 other identifier: E-10840098-772.02-5857
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aimed to evaluate how effective vestibular rehabilitation therapy (VRT) and Theta Binaural Beats (T-BB) are in reducing dizziness and anxiety in patients who continue to feel unsteady after successful treatment for a common inner ear condition called BPPV. A total of 56 adult patients were divided into three groups, each receiving different types of home-based exercises: Cawthorne-Cooksey Exercises (CCE), Brandt-Daroff Exercises (BDE), or CCE combined with T-BB. The study measured both physical balance and emotional symptoms such as anxiety. Results showed that all treatments helped, but patients who received CCE with T-BB showed the most improvement in both balance and anxiety levels. The findings suggest that combining physical and audio-based therapy may be especially helpful for people with ongoing dizziness after BPPV.

Conditions

BPPV; Residual Disease; Vestibular Disease

Keywords

Residual Dizziness; Theta Binaural Beats; Vestibular Rehabilitation; Computerized Dynamic Posturography

Outcome Measures

Primary Outcomes (1)

• Change in Sensory Organization Test (SOT) Scores from Baseline to Post-Intervention

  The Sensory Organization Test (SOT) is a computerized dynamic posturography tool used to assess balance performance under varying sensory conditions. The Composite Score is derived from multiple stance conditions that challenge somatosensory, visual, and vestibular input. Higher scores indicate better postural stability. Scores range from 0 to 100, where a score of 100 reflects perfect stability. The primary outcome is the change in Composite Score between the baseline (pre-intervention) and post-intervention assessments.

  Baseline and Week 4/6

Secondary Outcomes (2)

• Change in Dizziness Handicap Inventory (DHI) Total and Subscale Scores from Baseline to Post-Intervention

  Baseline and Week 4/6

• Change in State-Trait Anxiety Inventory (STAI) Scores from Baseline to Post-Intervention

  Baseline and Week 4/6

Study Arms (3)

Cawthorne-Cooksey Exercises (CCE) Group

EXPERIMENTAL

Participants in this group performed home-based Cawthorne-Cooksey vestibular rehabilitation exercises over a six-week period. Exercises were adjusted biweekly based on individual progress.

Behavioral: Cawthorne-Cooksey Exercises

CCE with Theta Binaural Beats (CCE+T-BB)

EXPERIMENTAL

Participants followed the same six-week Cawthorne-Cooksey protocol as Arm 1, with an additional 10-minute daily Theta Binaural Beats audio session via stereo headphones.

Behavioral: Cawthorne-Cooksey Exercises; Other: Theta Binaural Beats

Brandt-Daroff Exercises (BDE) Group

ACTIVE COMPARATOR

Participants performed traditional Brandt-Daroff Exercises three times daily for four weeks. Exercises were done at home using video instructions and monitored weekly.

Behavioral: Brandt-Daroff Exercises

Interventions

Cawthorne-Cooksey Exercises BEHAVIORAL

A set of vestibular rehabilitation exercises aimed at improving balance and reducing dizziness through repeated head and body movements, delivered via home-based digital instructions.

CCE with Theta Binaural Beats (CCE+T-BB); Cawthorne-Cooksey Exercises (CCE) Group

Brandt-Daroff Exercises BEHAVIORAL

A traditional home-based vestibular exercise program for treating positional dizziness, involving repetitive lateral head movements performed daily.

Brandt-Daroff Exercises (BDE) Group

Theta Binaural Beats OTHER

A digital auditory stimulation using two tones of slightly different frequencies to create a theta-frequency beat, intended to modulate anxiety and enhance vestibular rehabilitation effects.

CCE with Theta Binaural Beats (CCE+T-BB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with unilateral posterior canal benign paroxysmal positional vertigo (BPPV)
• Successfully treated with canalith repositioning procedures (CRP)
• Experiencing persistent dizziness or imbalance lasting at least 20 days after CRP
• Able and willing to perform home-based vestibular rehabilitation exercises
• Provided informed consent to participate in the study

You may not qualify if:

• Presence of other vestibular or neurological disorders (e.g., Meniere's disease, multiple sclerosis)
• History of psychiatric conditions that may interfere with participation
• Use of medications affecting vestibular function or anxiety within the last 4 weeks
• Conductive or sensorineural hearing loss
• Cognitive impairment or inability to follow digital instructions
• Previous participation in vestibular rehabilitation within the past 6 months

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasm, Residual; Vestibular Diseases

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants were assigned to one of three parallel intervention groups: Cawthorne-Cooksey Exercises (CCE), Brandt-Daroff Exercises (BDE), or CCE combined with Theta Binaural Beats (CCE+T-BB). Interventions were delivered concurrently across groups.

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: December 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)