BPPVNCT06936345
Effective Treatments for Dizziness After BPPV: A Clinical Study
A study testing Cawthorne-Cooksey Exercises, Brandt-Daroff Exercises and Theta Binaural Beats in people with BPPV and Residual Disease, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- BPPV, Residual Disease, Vestibular Disease
- What is being tested?
- Cawthorne-Cooksey Exercises, Brandt-Daroff Exercises and Theta Binaural Beats
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: EVALUATION OF EFFECTIVE METHODS IN THE TREATMENT OF RESIDUAL DIZZINESS AFTER BPPV: A PARTIALLY RANDOMIZED CONTROLLED CLINICAL STUDY
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.
Read the 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
- Being tested
- Cawthorne-Cooksey Exercises, Brandt-Daroff Exercises, Theta Binaural Beats
- Keywords
- Residual Dizziness, Theta Binaural Beats, Vestibular Rehabilitation, Computerized Dynamic Posturography
- Medical subject headings
- Neoplasm, Residual, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne-Cooksey ExercisesBehavioural
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.
Brandt-Daroff ExercisesBehavioural
A traditional home-based vestibular exercise program for treating positional dizziness, involving repetitive lateral head movements performed daily.
Theta Binaural BeatsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Brandt-Daroff Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 4/6
Secondary outcomes (2)
Change in Dizziness Handicap Inventory (DHI) Total and Subscale Scores from Baseline to Post-Intervention
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.
Measured: Baseline and Week 4/6
Change in State-Trait Anxiety Inventory (STAI) Scores from Baseline to Post-Intervention
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.
Measured: Baseline and Week 4/6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Dec 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPPVStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Ersin, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936345
- Sponsor's protocol ID
- E-10840098-772.02-5857
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) due to privacy concerns and the absence of institutional data-sharing agreements. Additionally, the nature of the intervention and follow-up data limits the feasibility of anonymized sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF EFFECTIVE METHODS IN THE TREATMENT OF RESIDUAL DIZZINESS AFTER BPPV: A PARTIALLY RANDOMIZED CONTROLLED CLINICAL STUDY
- ClinicalTrials.gov ID
- NCT06936345
- Acronym / sponsor ID
- E-10840098-772.02-5857
- Conditions
- BPPV, Residual Disease, Vestibular Disease
- Keywords
- Residual Dizziness, Theta Binaural Beats, Vestibular Rehabilitation, Computerized Dynamic Posturography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cawthorne-Cooksey Exercises (CCE) Group | Experimental | Behavioral: Cawthorne-Cooksey ExercisesParticipants in this group performed home-based Cawthorne-Cooksey vestibular rehabilitation exercises over a six-week period. Exercises were adjusted biweekly based on individual progress. |
| CCE with Theta Binaural Beats (CCE+T-BB) | Experimental | Behavioral: Cawthorne-Cooksey Exercises, Other: Theta Binaural BeatsParticipants 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. |
| Brandt-Daroff Exercises (BDE) Group | Active comparator | Behavioral: Brandt-Daroff ExercisesParticipants performed traditional Brandt-Daroff Exercises three times daily for four weeks. Exercises were done at home using video instructions and monitored weekly. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cawthorne-Cooksey ExercisesA set of vestibular rehabilitation exercises aimed at improving balance and reducing dizziness through repeated head and body movements, delivered via home-based digital instructions. | Behavioural | CCE with Theta Binaural Beats (CCE+T-BB), Cawthorne-Cooksey Exercises (CCE) Group |
| Brandt-Daroff ExercisesA traditional home-based vestibular exercise program for treating positional dizziness, involving repetitive lateral head movements performed daily. | Behavioural | Brandt-Daroff Exercises (BDE) Group |
| Theta Binaural BeatsA 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. | Other | CCE with Theta Binaural Beats (CCE+T-BB) |
Primary outcome
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.
2 secondary outcomes
Change in Dizziness Handicap Inventory (DHI) Total and Subscale Scores from Baseline to Post-Intervention
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) due to privacy concerns and the absence of institutional data-sharing agreements. Additionally, the nature of the intervention and follow-up data limits the feasibility of anonymized sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cawthorne-Cooksey Exercises, Brandt-Daroff Exercises and Theta Binaural Beats in people with BPPV and Residual Disease, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sensory Organization Test (SOT) Scores from Baseline to Post-Intervention (time frame: Baseline and Week 4/6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.