- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936345
Effective Treatments for Dizziness After BPPV: A Clinical Study
EVALUATION OF EFFECTIVE METHODS IN THE TREATMENT OF RESIDUAL DIZZINESS AFTER BPPV: A PARTIALLY RANDOMIZED CONTROLLED CLINICAL STUDY
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beykoz
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İstanbul, Beykoz, Turkey, 34810
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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.
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.
|
|
Active Comparator: 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.
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A traditional home-based vestibular exercise program for treating positional dizziness, involving repetitive lateral head movements performed daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sensory Organization Test (SOT) Scores from Baseline to Post-Intervention
Time Frame: Baseline and Week 4/6
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dizziness Handicap Inventory (DHI) Total and Subscale Scores from Baseline to Post-Intervention
Time Frame: Baseline and Week 4/6
|
The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire measuring the self-perceived impact of dizziness on daily life.
It includes three subscales: Functional, Emotional, and Physical.
Each item is scored from 0 (no handicap) to 4 (maximum handicap), and the total score ranges from 0 to 100.
Higher scores indicate more severe dizziness-related disability.
The outcome measure will capture changes in total and subscale scores from baseline to after the intervention.
|
Baseline and Week 4/6
|
|
Change in State-Trait Anxiety Inventory (STAI) Scores from Baseline to Post-Intervention
Time Frame: Baseline and Week 4/6
|
The STAI consists of two subscales measuring state anxiety (STAI-I) and trait anxiety (STAI-II), each containing 20 items scored on a 4-point Likert scale.
Total scores for each subscale range from 20 to 80, with higher scores reflecting greater anxiety.
This outcome measure assesses changes in both STAI-I and STAI-II scores between baseline and post-intervention evaluations.
|
Baseline and Week 4/6
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-5857
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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