Clinical trial NCT06936345: Effective Treatments for Dizziness After BPPV: A Clinical Study
Official title: EVALUATION OF EFFECTIVE METHODS IN THE TREATMENT OF RESIDUAL DIZZINESS AFTER BPPV: A PARTIALLY RANDOMIZED CONTROLLED CLINICAL STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPPV
Residual Disease
Vestibular Disease
Keywords: Residual Dizziness
Theta Binaural Beats
Vestibular Rehabilitation
Computerized Dynamic Posturography
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Sensory Organization Test (SOT) Scores from Baseline to Post-Intervention
timeFrame: Baseline and Week 4/6
Secondary outcomes:
measure: Change in Dizziness Handicap Inventory (DHI) Total and Subscale Scores from Baseline to Post-Intervention
timeFrame: Baseline and Week 4/6
measure: Change in State-Trait Anxiety Inventory (STAI) Scores from Baseline to Post-Intervention
timeFrame: Baseline and Week 4/6
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
References: