Benign Paroxysmal Positional Vertigo (BPPV)NCT07747376
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
A study testing Home-based therapy in people with Benign Paroxysmal Positional Vertigo (BPPV) and Vestibular Hypofunction, run by Muhammad Hizami bin Mustafa at 1 site in Malaysia.
Trial summary
The goal of this feasibility pilot randomised controlled trial is to determine whether a home-based exercise programme integrated with a self-managed education programme is feasible, acceptable, and safe for adults aged 60 years and older with benign paroxysmal positional vertigo (BPPV) with and without vestibular… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction
- What is being tested?
- Home-based therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 4 May 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as benign paroxysmal positional vertigo by an otolaryngologist or Medical Doctor at the Ear, Nose, and Throat Clinic Hospital Pulau Pinang
- Aged 60 years and older
- Do not receive treatment from outside Hospital Pulau Pinang
Who cannot join
- Severe neurological conditions, including stroke or peripheral neuropathy
- Severe musculoskeletal disorders such as fractures, rheumatoid arthritis, or recent injuries that limit movement
- • Clinically diagnosed hearing or visual impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Home-based Exercise Programme Integrated With a Self-managed Education Programme in People With Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction
The goal of this feasibility pilot randomised controlled trial is to determine whether a home-based exercise programme integrated with a self-managed education programme is feasible, acceptable, and safe for adults aged 60 years and older with benign paroxysmal positional vertigo (BPPV) with and without vestibular hypofunction. The study will also evaluate whether the trial procedures are suitable for a future definitive randomised controlled trial.
The main questions it aims to answer are:
Read more
Can participants follow the programme as planned? Can participants be retained throughout the 20-week study? Is the programme acceptable to participants? Do participants experience any adverse events? Do the clinical outcomes show preliminary changes that support further investigation?
Researchers will randomly assign participants to receive either the home-based exercise and self-managed education programme or standard care alone. Preliminary changes in dizziness, balance confidence, gait performance, fall risk, physical activity, and health-related quality of life will be explored. As this is a feasibility pilot study, it is not designed to provide definitive evidence of effectiveness.
Participants will:
Take part in the study for 20 weeks Follow their assigned intervention or standard care as instructed Complete assessments at baseline, week 10, and week 20 Report their adherence, experience with the programme, and any adverse events during the study
- Being tested
- Home-based therapy, Standard Care (in control arm)
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based therapyOther
The intervention combines structured, progressive home-based exercises with a self-managed education resource. The exercises are based on vestibular rehabilitation principles and target movement-related dizziness, gaze stability, postural balance, gait, and functional mobility. Participants receive an illustrated booklet containing step-by-step exercise instructions, guidance on gradual progression and rest periods, and safety precautions. Exercise progression is adapted according to the participant's functional ability and symptom response. The education component addresses understanding of BPPV and vestibular hypofunction, safe exercise performance, symptom self-management, adherence, and when to seek professional advice. Participants are instructed to discontinue an exercise and obtain appropriate clinical advice if severe or worsening symptoms occur.
Standard Care (in control arm)Other
Standard care consists of routine clinical management for BPPV with and without vestibular hypofunction provided at the study site. Treatment includes a canalith repositioning manoeuvre selected according to the affected semicircular canal and side, together with routine clinical advice and follow-up. Any additional management is determined by the treating clinician according to the participant's clinical needs and usual practice at the study site.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Home-based therapy |
| Standard care | Active comparator | Not described Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Activities-specific Balance Confidence Scale
Measured: From enrollment to the end of treatment at 20 weeks
Dizziness Handicap Inventory
Measured: From enrollment to the end of treatment at 20 weeks
Dynamic Gait Index
Measured: From enrollment to the end of treatment at 20 weeks
Timed Up and Go
Measured: From enrollment to the end of treatment at 20 weeks
5 Times Sit To Stand
Measured: From enrollment to the end of treatment at 8 weeks
EQ-5D-5L
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start4 May 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional Vertigo (BPPV)Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Hizami bin Mustafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Hizami bin Mustafa, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747376
- Sponsor's protocol ID
- NMRR ID-25-03771-REH (IIR)
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because external sharing of participant-level data is not included in the ethics-approved data-management plan or participant consent process. Furthermore, the small, single-site sample and detailed clinical information may increase the risk of participant re-identification, even after de-identification. Study findings will be disseminated only in aggregated form through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Home-based Exercise Programme Integrated With a Self-managed Education Programme in People With Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT07747376
- Acronym / sponsor ID
- NMRR ID-25-03771-REH (IIR)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muhammad Hizami bin MustafaUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Aug 2026 (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.
The goal of this feasibility pilot randomised controlled trial is to determine whether a home-based exercise programme integrated with a self-managed education programme is feasible, acceptable, and safe for adults aged 60 years and older with benign paroxysmal positional vertigo (BPPV) with and without vestibular hypofunction. The study will also evaluate whether the trial procedures are suitable for a future definitive randomised controlled trial.
The main questions it aims to answer are:
Can participants follow the programme as planned? Can participants be retained throughout the 20-week study? Is the programme acceptable to participants? Do participants experience any adverse events? Do the clinical outcomes show preliminary changes that support further investigation?
Researchers will randomly assign participants to receive either the home-based exercise and self-managed education programme or standard care alone. Preliminary changes in dizziness, balance confidence, gait performance, fall risk, physical activity, and health-related quality of life will be explored. As this is a feasibility pilot study, it is not designed to provide definitive evidence of effectiveness.
Participants will:
Take part in the study for 20 weeks Follow their assigned intervention or standard care as instructed Complete assessments at baseline, week 10, and week 20 Report their adherence, experience with the programme, and any adverse events during the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Home-based therapy |
| Standard care | Active comparator | Other: Standard Care (in control arm) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as benign paroxysmal positional vertigo by an otolaryngologist or Medical Doctor at the Ear, Nose, and Throat Clinic Hospital Pulau Pinang
- Aged 60 years and older
- Do not receive treatment from outside Hospital Pulau Pinang
Key exclusion criteria (3 listed)
- Severe neurological conditions, including stroke or peripheral neuropathy
- Severe musculoskeletal disorders such as fractures, rheumatoid arthritis, or recent injuries that limit movement
- • Clinically diagnosed hearing or visual impairments
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 |
|---|---|---|
| Home-based therapyThe intervention combines structured, progressive home-based exercises with a self-managed education resource. The exercises are based on vestibular rehabilitation principles and target movement-related dizziness, gaze stability, postural balance, gait, and functional mobility. Participants receive an illustrated booklet containing step-by-step exercise instructions, guidance on gradual progression and rest periods, and safety precautions. Exercise progression is adapted according to the participant's functional ability and symptom response. The education component addresses understanding of BPPV and vestibular hypofunction, safe exercise performance, symptom self-management, adherence, and when to seek professional advice. Participants are instructed to discontinue an exercise and obtain appropriate clinical advice if severe or worsening symptoms occur. | Other | Intervention |
| Standard Care (in control arm)Standard care consists of routine clinical management for BPPV with and without vestibular hypofunction provided at the study site. Treatment includes a canalith repositioning manoeuvre selected according to the affected semicircular canal and side, together with routine clinical advice and follow-up. Any additional management is determined by the treating clinician according to the participant's clinical needs and usual practice at the study site. | Other | Standard care |
Primary outcome
The Activities-specific Balance Confidence Scale
Time frame: From enrollment to the end of treatment at 20 weeks
Dizziness Handicap Inventory
Time frame: From enrollment to the end of treatment at 20 weeks
Dynamic Gait Index
Time frame: From enrollment to the end of treatment at 20 weeks
Timed Up and Go
Time frame: From enrollment to the end of treatment at 20 weeks
5 Times Sit To Stand
Time frame: From enrollment to the end of treatment at 8 weeks
EQ-5D-5L
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because external sharing of participant-level data is not included in the ethics-approved data-management plan or participant consent process. Furthermore, the small, single-site sample and detailed clinical information may increase the risk of participant re-identification, even after de-identification. Study findings will be disseminated only in aggregated form through scientific publications and presentations.
Related trials for Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
RecruitingObservational study
Association Between Benign Paroxysmal Positional Vertigo and Vitamin D Deficiency .
Benign Paroxysmal Positional Vertigo (BPPV)
Recruiting
Testing the Epley Maneuver for Treating Dizziness in the Emergency Department
Benign Paroxysmal Positional Vertigo (BPPV)
RecruitingObservational study
Heart Rate Variability in Benign Paroxysmal Positional Vertigo
BPPV, Stress and Anxiety
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 Home-based therapy in people with Benign Paroxysmal Positional Vertigo (BPPV) and Vestibular Hypofunction, run by Muhammad Hizami bin Mustafa at 1 site in Malaysia.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Activities-specific Balance Confidence Scale (time frame: From enrollment to the end of treatment at 20 weeks). The study lists 6 primary outcomes in all. 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 5 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.