NCT05309538

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
Last Updated

April 4, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

March 24, 2022

Last Update Submit

April 1, 2022

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

BPPV

Outcome Measures

Primary Outcomes (2)

  • DHI

    dizziness handicap inventery

    1 month

  • EQ-5D-5L

    quality of life

    1 month

Study Arms (2)

Group A

ACTIVE COMPARATOR

Control group

Other: Modified eply & Semont maneuver

group B

EXPERIMENTAL

experimental group

Other: betahistine & Modified eply & Semont maneuver

Interventions

Modified eply & Semont maneuverOTHER

repositioning maneauvers

Group A
betahistine & Modified eply & Semont maneuverOTHER

antihistamine plus repositioning maneuvers

Also known as: Modified eply & Semont maneuver
group B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18-60
  • positive modified Dix Hil pike test
  • repetitive vertigo spells affecting activities of daily livings (ADLs)

You may not qualify if:

  • any cervical spine problem
  • vertigo due to central disease
  • tumors
  • systemic disease
  • cardiac disease
  • Parkinson disease
  • bed bound patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Neurocouncil Clinic

Islamabad, Fedral, 44010, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 30828628BACKGROUND

  • Kerber 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.

    PMID: 23264119BACKGROUND

  • Kitanaka 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.

    PMID: 32387137BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Interventions

Betahistine

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • MUHAMMAD SALMAN, M.Phil*

    the neurocouncil hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups , group A contro group and group B experimental group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 4, 2022

Study Start

January 2, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

April 4, 2022

Record last verified: 2022-04

Locations

PA(1)