Benign Paroxysmal Positional Vertigo (BPPV)NCT02701218
BPPV With CRP: Single Versus Multiple Cycles
A study testing Canalith repositioning procedure in people with Benign Paroxysmal Positional Vertigo (BPPV), run by Chiang Mai University at 1 site in Thailand.
Trial summary
Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be randomized to treat with single or multiple cycles of canalith repositioning procedure.The treatment outcomes will be assessed at 7th and 28th days. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (BPPV)
- What is being tested?
- Canalith repositioning procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2016to Dec 2019
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recurrent episodes of vertigo
- 15 years of age or older
- Positive Dix-Hallpike test: unilateral, posterior canal
Who cannot join
- Received vestibular suppressant within 6 hours
- With other diseases or conditions cause of vertigo or central nervous system disease
- With diseases or conditions contraindicate for Dix-Hallpike test or CRP eg: cervical spine disease, back/ neck stiffness, retinal detachment
- Positive Dix-Hallpike test: bilateral, other canals
- Complications from CRP eg: nausea, vomiting, canalith jam
- Cannot read the questionaire
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
Chiang Mai, 50200
Suwicha I Kaewsiri, MD, 66-816802036, suwicha.kaewsiri@cmu.ac.th
Sanathorn Chowsilpa, MD, 66-53935562, sanathornch@hotmail.com
About this study
Official title: Comparison of the Treatment Outcomes of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) With Canalith Repositioning Procedure (CRP): Single Versus Multiple Cycles
Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be randomized to treat with single or multiple cycles of canalith repositioning procedure.The treatment outcomes will be assessed at 7th and 28th days.
Read the detailed description
Patients present with brief episodes of vertigo will be evaluated by Dix-Hallpike test. Cases with positive Dix-Hallpike test, unilateral, posterior canal, will be randomized with block of four. Either single or multiple cycles of canalith repositioning procedure will be performed. Four treatment outcomes will be blindly assessed at 7 and 28 days.
- Being tested
- Canalith repositioning procedure
- Keywords
- Canalith repositioning procedure (CRP), BPPV
- 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.
Canalith repositioning procedureProcedure or surgery
Also called Epley's maneuver
Canalith repositioning procedure; single or multiple cycles
| Study group | Role | What they receive |
|---|---|---|
| Single cycle | Experimental | single cycle of canalith repositioning procedure Receives: Procedure: Canalith repositioning procedure |
| multiple cycles of CRP | Experimental | multiple cycles of canalith repositioning procedure CRP will be stopped if 1) no nystagmus and vertigo in all positions 2) complications exited 3) stable nystagmus in the 2 last cycles Receives: Procedure: Canalith repositioning procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dix-Hallpike test (DHT)
percentage of negative DHT between single and multiple cycles
Measured: At 7th day
Secondary outcomes (7)
Dizziness handicap inventory (DHI)
total score in the questionaire
Measured: compare to the first visit at 7th between single and multiple cycles
Dizziness handicap inventory (DHI)
total score in the questionaire
Measured: compare to the first visit at 28th day between single and multiple cycles
Subjective symptoms
Asking the patient's symptom: Improve, same, worse
Measured: Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles
Subjective symptoms
Asking the patient's symptom: Improve, same, worse
Measured: Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles
Loss of balance
5 levels Level 1: Able to continue daily activities without any helps. Level 2: Able to continue daily activities without any helps except complicated activities such as riding a bicycle, walking on counterpoise or scaffolding.
Level 3: Not able to continue daily activities without help excepts simple activities such as self-care, housework, walking, or being a passenger in a vehicle Level 4: Not able to continue daily activities alone without help except self-care Level 5 Not able to continue daily activities alone without help except self-care without ambulation. Need to stay only in a house or a living place.
(From: The Royal college of Otolaryngologists head and neck surgeons of Thailand, and social security office of thailand)
Measured: compare to the first visit at 7th between single and multiple cycles
Loss of balance
5 levels Level 1: Able to continue daily activities without any helps. Level 2: Able to continue daily activities without any helps except complicated activities such as riding a bicycle, walking on counterpoise or scaffolding.
Level 3: Not able to continue daily activities without help excepts simple activities such as self-care, housework, walking, or being a passenger in a vehicle Level 4: Not able to continue daily activities alone without help except self-care Level 5 Not able to continue daily activities alone without help except self-care without ambulation. Need to stay only in a house or a living place.
(From: The Royal college of Otolaryngologists head and neck surgeons of Thailand, and social security office of thailand)
Measured: compare to the first visit at 28th day between single and multiple cycles
Dix-Hallpike test (DHT)
percentage of negative DHT between single and multiple cycles
Measured: At 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2019
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwicha Isaradisaikul Kaewsiri, Chiang Mai University
- Investigators
- Suwicha I Kaewsiri, MD, Principal investigator, Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701218
- Sponsor's protocol ID
- ENT-2558-03601
- Status last verified
- Jul 2019
- First submitted
- 18 Feb 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bhattacharyya N, Baugh RF, Orvidas L, Barrs D, Bronston LJ, Cass S, Chalian AA, Desmond AL, Earll JM, Fife TD, Fuller DC, Judge JO, Mann NR, Rosenfeld RM, Schuring LT, Steiner RW, Whitney SL, Haidari J; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 2008 Nov;139(5 Suppl 4):S47-81. doi: 10.1016/j.otohns.2008.08.022.
PubMed 18973840Isaradisaikul SK, Chowsilpa S, Hanprasertpong C, Rithirangsriroj T. Single Cycle Versus Multiple Cycles of Canalith Repositioning Procedure for Treatment of Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial. Otol Neurotol. 2021 Jan;42(1):121-128. doi: 10.1097/MAO.0000000000002894.
PubMed 32947492
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Treatment Outcomes of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) With Canalith Repositioning Procedure (CRP): Single Versus Multiple Cycles
- ClinicalTrials.gov ID
- NCT02701218
- Acronym / sponsor ID
- ENT-2558-03601
- Keywords
- Canalith repositioning procedure (CRP), BPPV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- 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.
Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be randomized to treat with single or multiple cycles of canalith repositioning procedure.The treatment outcomes will be assessed at 7th and 28th days.
Detailed description
Patients present with brief episodes of vertigo will be evaluated by Dix-Hallpike test. Cases with positive Dix-Hallpike test, unilateral, posterior canal, will be randomized with block of four. Either single or multiple cycles of canalith repositioning procedure will be performed. Four treatment outcomes will be blindly assessed at 7 and 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single cycle | Experimental | Procedure: Canalith repositioning proceduresingle cycle of canalith repositioning procedure |
| multiple cycles of CRP | Experimental | Procedure: Canalith repositioning proceduremultiple cycles of canalith repositioning procedure CRP will be stopped if 1) no nystagmus and vertigo in all positions 2) complications exited 3) stable nystagmus in the 2 last cycles |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent episodes of vertigo
- 15 years of age or older
- Positive Dix-Hallpike test: unilateral, posterior canal
Key exclusion criteria (6 listed)
- Received vestibular suppressant within 6 hours
- With other diseases or conditions cause of vertigo or central nervous system disease
- With diseases or conditions contraindicate for Dix-Hallpike test or CRP eg: cervical spine disease, back/ neck stiffness, retinal detachment
- Positive Dix-Hallpike test: bilateral, other canals
- Complications from CRP eg: nausea, vomiting, canalith jam
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 |
|---|---|---|
| Canalith repositioning procedureAlso: Epley's maneuverCanalith repositioning procedure; single or multiple cycles | Procedure or surgery | Single cycle, multiple cycles of CRP |
Primary outcome
Dix-Hallpike test (DHT)
Time frame: At 7th day
percentage of negative DHT between single and multiple cycles
7 secondary outcomes
Dizziness handicap inventory (DHI)
Time frame: compare to the first visit at 7th between single and multiple cycles
Dizziness handicap inventory (DHI)
Time frame: compare to the first visit at 28th day between single and multiple cycles
Subjective symptoms
Time frame: Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles
Subjective symptoms
Time frame: Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles
Loss of balance
Time frame: compare to the first visit at 7th between single and multiple cycles
Loss of balance
Time frame: compare to the first visit at 28th day between single and multiple cycles
Dix-Hallpike test (DHT)
Time frame: At 28th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Results publication: PubMed 18973840Bhattacharyya N, Baugh RF, Orvidas L, Barrs D, Bronston LJ, Cass S, Chalian AA, Desmond AL, Earll JM, Fife TD, Fuller DC, Judge JO, Mann NR, Rosenfeld RM, Schuring LT, Steiner RW, Whitney SL, Haidari J; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 2008 Nov;139(5 Suppl 4):S47-81. doi: 10.1016/j.otohns.2008.08.022.
- Derived from this study: PubMed 32947492Isaradisaikul SK, Chowsilpa S, Hanprasertpong C, Rithirangsriroj T. Single Cycle Versus Multiple Cycles of Canalith Repositioning Procedure for Treatment of Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial. Otol Neurotol. 2021 Jan;42(1):121-128. doi: 10.1097/MAO.0000000000002894.
- Individual participant dataSharing planned: Undecided
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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.
Suwicha I Kaewsiri, MD principal investigator
Department of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canalith repositioning procedure in people with Benign Paroxysmal Positional Vertigo (BPPV), run by Chiang Mai University at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suwicha I Kaewsiri, MD (66-816802036, suwicha.kaewsiri@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dix-Hallpike test (DHT) (time frame: At 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701218, which also lists 2 linked publications.
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 31 Jul 2019.