Effective Treatments for Dizziness After BPPV: A Clinical Study

NCT ID: NCT06936345

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-01-01

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.

Detailed Description

Residual dizziness (RD) is a common yet often overlooked condition that can persist after successful canalith repositioning procedures (CRP) for benign paroxysmal positional vertigo (BPPV). Despite the resolution of vertigo, many patients continue to report imbalance and anxiety, which may affect their quality of life. This study investigated whether vestibular rehabilitation therapies-specifically Cawthorne-Cooksey Exercises (CCE), Brandt-Daroff Exercises (BDE), and CCE combined with Theta Binaural Beats (CCE+T-BB)-could improve balance and reduce anxiety in patients experiencing RD.

Fifty-six adults aged 18-60 who reported dizziness for at least 20 days after CRP were enrolled. Participants were assigned to one of the three intervention groups based on auditory sensitivity. The interventions were home-based, guided by digital content through the Moodle platform, and lasted four to six weeks depending on the protocol. The CCE+T-BB group also received 10-minute daily auditory stimulation designed to modulate brainwave activity and support emotional regulation.

The study used both objective (Sensory Organization Test - SOT) and subjective (Dizziness Handicap Inventory - DHI, State-Trait Anxiety Inventory - STAI) tools to assess outcomes before and after the interventions. All groups showed improvements, but the CCE+T-BB group demonstrated superior gains in balance, especially under visually and vestibular-dependent conditions. Both CCE-based groups had significant reductions in trait and state anxiety, while the BDE group only showed improvement in trait anxiety.

These findings suggest that structured vestibular rehabilitation improves balance and reduces anxiety in patients with residual dizziness. Furthermore, adding auditory neuromodulation (T-BB) to CCE may enhance postural adaptation and emotional regulation, supporting a multimodal, non-pharmacological approach to RD management. This research represents the first clinical evaluation of Theta Binaural Beats as an adjunct to vestibular therapy and offers a promising direction for personalized rehabilitation.

Conditions

BPPV; Residual Disease; Vestibular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cawthorne-Cooksey Exercises (CCE) Group

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.

Group Type: EXPERIMENTAL

Cawthorne-Cooksey Exercises

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

Cawthorne-Cooksey Exercises

Intervention Type: 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.

Theta Binaural Beats

Intervention Type: 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.

Brandt-Daroff Exercises (BDE) Group

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

Group Type: ACTIVE_COMPARATOR

Brandt-Daroff Exercises

Intervention Type: BEHAVIORAL

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

Interventions

Cawthorne-Cooksey Exercises

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.

Intervention Type: BEHAVIORAL

Brandt-Daroff Exercises

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

Intervention Type: BEHAVIORAL

Theta Binaural Beats

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Kerem Ersin

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-5857

Identifier Type: -

Identifier Source: org_study_id