Benign Paroxysmal Positional VertigoNCT05309538
Paroxysmal Positional Vertigo & Repositioning Maneuvers
A study testing Modified eply & Semont maneuver and betahistine & Modified eply & Semont maneuver in people with Benign Paroxysmal Positional Vertigo, run by Neuro Counsel Hospital, Pakistan at 1 site in Pakistan.
Trial summary
: Benign Paroxysmal Positional Vertigo is a condition related to vestibular system accompanied by dizziness, tinnitus and balance problems leading to increased fall risk and potential disability. Various treatment options are available including pharmacotherapy and vestibular rehabilitation with varied results Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Modified eply & Semont maneuver and betahistine & Modified eply & Semont maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2021to 1 Jan 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18-60
- positive modified Dix Hil pike test
- repetitive vertigo spells affecting activities of daily livings (ADLs)
Who cannot join
- any cervical spine problem
- vertigo due to central disease
- tumors
- systemic disease
- cardiac disease
- Parkinson disease
- bed bound patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Modified Epley's & Semont's Maneuvers With or Without Beta-histine on Benign Paroxysmal Positional Vertigo: A Randomized Control Trail
: Benign Paroxysmal Positional Vertigo is a condition related to vestibular system accompanied by dizziness, tinnitus and balance problems leading to increased fall risk and potential disability. Various treatment options are available including pharmacotherapy and vestibular rehabilitation with varied results
Read the detailed description
Objective: The objective of this study was to compare the efficacy of Modified Epley \& Semont's maneuver with and without Betahistine for BPPV Material \& Methods: The study was a single blind randomized control trail. Total number of patients were 97 as calculated by Epitool calculator. Duration of the study was of one year from 2 January 2021 to 1st January 2022. Out of a total 97 patients, 90 met the inclusion criteria. These participants were randomized by lottery method into two equal groups. Group A (control group) was receiving both maneuvers only while group B (experimental group) included participants receiving betahistine along with both maneuvers. The impact of dizziness and quality of life was measured through EQ-5D-5L questionnaire and dizziness handicap inventory (DHI) in order to analyze the effectiveness of treatments. Pre and Post treatment results were compared within group by Wilcoxon rank test and for between groups, Mann Whitney U test was performed
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Modified eply & Semont maneuver, betahistine & Modified eply & Semont maneuver
- Keywords
- 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.
Modified eply & Semont maneuverOther
repositioning maneauvers
betahistine & Modified eply & Semont maneuverOther
Also called Modified eply & Semont maneuver
antihistamine plus repositioning maneuvers
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Control group Receives: Other: Modified eply & Semont maneuver |
| group B | Experimental | experimental group Receives: Other: betahistine & Modified eply & Semont maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
DHI
dizziness handicap inventery
Measured: 1 month
EQ-5D-5L
quality of life
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start2 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies 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
- Model description
- 2 groups , group A contro group and group B experimental group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuro Counsel Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MUHAMMAD SALMAN, M.Phil*, Principal investigator, the neurocouncil hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309538
- Sponsor's protocol ID
- 336
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we would share with other researcher so that they might be able to find study gaps
Publications
You P, Instrum R, Parnes L. Benign paroxysmal positional vertigo. Laryngoscope Investig Otolaryngol. 2018 Dec 14;4(1):116-123. doi: 10.1002/lio2.230. eCollection 2019 Feb.
PubMed 30828628Kerber KA, Burke JF, Skolarus LE, Meurer WJ, Callaghan BC, Brown DL, Lisabeth LD, McLaughlin TJ, Fendrick AM, Morgenstern LB. Use of BPPV processes in emergency department dizziness presentations: a population-based study. Otolaryngol Head Neck Surg. 2013 Mar;148(3):425-30. doi: 10.1177/0194599812471633. Epub 2012 Dec 21.
PubMed 23264119Kitanaka J, Kitanaka N, Hall FS, Amatsu Y, Hashimoto K, Hisatomi E, Kitao E, Mimura M, Nakamura M, Ozawa R, Sato M, Tagami K, Uhl GR, Takemura M. In vivo evaluation of effects of histamine H3 receptor antagonists on methamphetamine-induced hyperlocomotion in mice. Brain Res. 2020 Aug 1;1740:146873. doi: 10.1016/j.brainres.2020.146873. Epub 2020 May 5.
PubMed 32387137
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Epley's & Semont's Maneuvers With or Without Beta-histine on Benign Paroxysmal Positional Vertigo: A Randomized Control Trail
- ClinicalTrials.gov ID
- NCT05309538
- Acronym / sponsor ID
- 336
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- BPPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Neuro Counsel Hospital, PakistanUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 4 Apr 2022 (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.
: Benign Paroxysmal Positional Vertigo is a condition related to vestibular system accompanied by dizziness, tinnitus and balance problems leading to increased fall risk and potential disability. Various treatment options are available including pharmacotherapy and vestibular rehabilitation with varied results
Detailed description
Objective: The objective of this study was to compare the efficacy of Modified Epley \& Semont's maneuver with and without Betahistine for BPPV Material \& Methods: The study was a single blind randomized control trail. Total number of patients were 97 as calculated by Epitool calculator. Duration of the study was of one year from 2 January 2021 to 1st January 2022. Out of a total 97 patients, 90 met the inclusion criteria. These participants were randomized by lottery method into two equal groups. Group A (control group) was receiving both maneuvers only while group B (experimental group) included participants receiving betahistine along with both maneuvers. The impact of dizziness and quality of life was measured through EQ-5D-5L questionnaire and dizziness handicap inventory (DHI) in order to analyze the effectiveness of treatments. Pre and Post treatment results were compared within group by Wilcoxon rank test and for between groups, Mann Whitney U test was performed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups , group A contro group and group B experimental group
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Modified eply & Semont maneuverControl group |
| group B | Experimental | Other: betahistine & Modified eply & Semont maneuverexperimental group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18-60
- positive modified Dix Hil pike test
- repetitive vertigo spells affecting activities of daily livings (ADLs)
Key exclusion criteria (7 listed)
- any cervical spine problem
- vertigo due to central disease
- tumors
- systemic disease
- cardiac disease
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 |
|---|---|---|
| Modified eply & Semont maneuverrepositioning maneauvers | Other | Group A |
| betahistine & Modified eply & Semont maneuverAlso: Modified eply & Semont maneuverantihistamine plus repositioning maneuvers | Other | group B |
Primary outcome
DHI
Time frame: 1 month
dizziness handicap inventery
EQ-5D-5L
Time frame: 1 month
quality of life
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 4 Apr 2022.
- Background: PubMed 30828628You P, Instrum R, Parnes L. Benign paroxysmal positional vertigo. Laryngoscope Investig Otolaryngol. 2018 Dec 14;4(1):116-123. doi: 10.1002/lio2.230. eCollection 2019 Feb.
- Background: PubMed 23264119Kerber KA, Burke JF, Skolarus LE, Meurer WJ, Callaghan BC, Brown DL, Lisabeth LD, McLaughlin TJ, Fendrick AM, Morgenstern LB. Use of BPPV processes in emergency department dizziness presentations: a population-based study. Otolaryngol Head Neck Surg. 2013 Mar;148(3):425-30. doi: 10.1177/0194599812471633. Epub 2012 Dec 21.
- Background: PubMed 32387137Kitanaka J, Kitanaka N, Hall FS, Amatsu Y, Hashimoto K, Hisatomi E, Kitao E, Mimura M, Nakamura M, Ozawa R, Sato M, Tagami K, Uhl GR, Takemura M. In vivo evaluation of effects of histamine H3 receptor antagonists on methamphetamine-induced hyperlocomotion in mice. Brain Res. 2020 Aug 1;1740:146873. doi: 10.1016/j.brainres.2020.146873. Epub 2020 May 5.
- Individual participant dataSharing planned: Undecided. we would share with other researcher so that they might be able to find study gaps
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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.
MUHAMMAD SALMAN, M.Phil* principal investigator
the neurocouncil hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified eply & Semont maneuver and betahistine & Modified eply & Semont maneuver in people with Benign Paroxysmal Positional Vertigo, run by Neuro Counsel Hospital, Pakistan at 1 site in Pakistan.
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 7 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 4 Apr 2022. 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 Pakistan. 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?
DHI (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT05309538, which also lists 3 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 4 Apr 2022.