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
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:
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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.