NCT02701218

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

February 18, 2016

Last Update Submit

July 30, 2019

Conditions

Benign Paroxysmal Positional Vertigo (BPPV)

Keywords

Canalith repositioning procedure (CRP)BPPV

Outcome Measures

Primary Outcomes (1)

  • Dix-Hallpike test (DHT)

    percentage of negative DHT between single and multiple cycles

    At 7th day

Secondary Outcomes (7)

  • Dizziness handicap inventory (DHI)

    compare to the first visit at 7th between single and multiple cycles

  • Dizziness handicap inventory (DHI)

    compare to the first visit at 28th day between single and multiple cycles

  • Subjective symptoms

    Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles

  • Subjective symptoms

    Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles

  • Loss of balance

    compare to the first visit at 7th between single and multiple cycles

  • +2 more secondary outcomes

Study Arms (2)

Single cycle

EXPERIMENTAL

single cycle of canalith repositioning procedure

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

Procedure: Canalith repositioning procedure

Interventions

Canalith repositioning procedurePROCEDURE

Canalith repositioning procedure; single or multiple cycles

Also known as: Epley's maneuver
Single cyclemultiple cycles of CRP

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent episodes of vertigo
  • years of age or older
  • Positive Dix-Hallpike test: unilateral, posterior canal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum

Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (2)

  • 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.

    PMID: 18973840RESULT

  • Isaradisaikul 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.

    PMID: 32947492DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

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

Study Officials

  • Suwicha I Kaewsiri, MD

    Department of Otolaryngology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suwicha I Kaewsiri, MD

CONTACT

66-816802036suwicha.kaewsiri@cmu.ac.th

Sanathorn Chowsilpa, MD

CONTACT

66-53935562sanathornch@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 8, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

TH(1)