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Comparison of the treatment effect of the modified Epley maneuver vs. simplified Epley maneuver for the benign paroxysmal positional vertigo involving posterior semicircular canal : Double-Blind, Randomized, Multi-center, Efficacy Trial.

Status Approved

First Submitted Date

2021/02/03
Registered Date

2021/02/18
Last Updated Date

2021/02/03

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005904
Unique Protocol ID	B-2012/657-306
Public/Brief Title	Comparison of the treatment effect of the modified Epley maneuver vs. simplified Epley maneuver for the posterior canal benign paroxysmal positional vertigo
Scientific Title	Comparison of the treatment effect of the modified Epley maneuver vs. simplified Epley maneuver for the benign paroxysmal positional vertigo involving posterior semicircular canal : Double-Blind, Randomized, Multi-center, Efficacy Trial.
Acronym	Simplified Epley
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-2012/657-306
Approval Date	2020-12-24
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Ji-Soo Kim
Title	Professor
Telephone	+82-31-787-7463
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	Hyo-Jung Kim
Title	Research Professor
Telephone	+82-31-787-8401
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Hyo-Jung Kim
Title	Research Professor
Telephone	+82-31-787-8401
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 4
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-02-08 Actual
Target Number of Participant	120
Primary Completion Date
Study Completion Date
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-02-08 ,
Recruitment Status by Participating Study Site 2
Name of Study	Pusan National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-02-22 ,
Recruitment Status by Participating Study Site 3
Name of Study	Kangdong Sacred Heart Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-02-22 ,
Recruitment Status by Participating Study Site 4
Name of Study	Korea University Anam Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-02-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	- Benign paroxysmal positional vertigo (BPPV) can be treated with canalith repositioning procedures (CRPs). - The modified Epley maneuver is mostly adopted for BPPV involving the posterior canal (PC-BPPV). - To diagnose and apply the modified maneuver, the Dix-Hallpike positioning maneuver should be performed in either direction. - Patients with PC-BPPV mostly show ipsiversive torsional and upbeat nystagmus during straight head hanging (SHH). - Thus, the repositioning maneuver may be attempted from the SHH (simplified Epley maneuver) when the patients with PC-BPPV show the typical pattern of torsional and upbeat positional nystagmus during SHH. - This study aims to determine the therapeutic efficacy of this simplified Epley maneuver in comparison to the classic modified Epley maneuver for PC-BPPV by adopting a double-blinded randomized controlled trial.

Study Summary Information

Lay Summary

- Benign paroxysmal positional vertigo (BPPV) can be treated with canalith repositioning procedures (CRPs).
- The modified Epley maneuver is mostly adopted for BPPV involving the posterior canal (PC-BPPV).
- To diagnose and apply the modified maneuver, the Dix-Hallpike positioning maneuver should be performed in either direction.
- Patients with PC-BPPV mostly show ipsiversive torsional and upbeat nystagmus during straight head hanging (SHH).
- Thus, the repositioning maneuver may be attempted from the SHH (simplified Epley maneuver) when the patients with PC-BPPV show the typical pattern of torsional and upbeat positional nystagmus during SHH.
- This study aims to determine the therapeutic efficacy of this simplified Epley maneuver in comparison to the classic modified Epley maneuver for PC-BPPV by adopting a double-blinded randomized controlled trial.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	/Procedure/Surgery, Others (canalith repositioning procedures)
Intervention Description	The starting positions of the canalith repositioning therapy are different between the modified (Dix-Hallpike position to the involved canal side) and simplified (SHH position) maneuvers.
Number of Arms	2
Arm 1	Arm Label Simplified Epley maneuver
	Target Number of Participant 60
	Arm Type Experimental
	Arm Description Simplified Epley maneuver -Sit on the bed and lie on subject's back so the head can be tilted about 100-120 degrees. -Turn the head 45 degrees away from the lesion. -Turn subject's head 90 degrees away from the lesion. -Fix the position of subject's head as much as possible and sit up with the body up.
Arm 2	Arm Label Modified Epley maneuver
	Target Number of Participant 60
	Arm Type Active comparator
	Arm Description Modified Epley maneuver -Sit on the bed, turn the head 45 degrees toward the lesion, and lie on subject's back so the head can be tilted about 100-120 degrees. -Turn the head 45 degrees away from the lesion. -Turn subject's head 90 degrees away from the lesion. -Fix the position of subject's head as much as possible and sit up with the body up.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H60-H95)Diseases of the ear and mastoid process (H81.1)Benign paroxysmal vertigo Benign Paroxysmal Positional Vertigo
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description A) Recurrent attacks of positional vertigo or positional dizziness provoked by lying down or turning over in the supine position. B) Duration of attacks < 1 min. C) Positional nystagmus elicited after a latency of one or few seconds by the straight head hanging test The nystagmus is a combination of torsional nystagmus with the upper pole of the eyes beating toward the lower ear combined with vertical nystagmus beating upward (toward the forehead) typically lasting < 1 minute D) Not attributable to another disorder. E) Subjects over 19 years old F) Subjects who agree to participate in this clinical trial
Exclusion Criteria	A) Minors under the age of 19 B) Subjects diagnosed with bilateral PC-BPPV C) The positional nystagmus lasts more than 1 minute D) When it is not possible to perform CRP due to spinal lesion, severe obesity, severe pain, pregnancy, etc. E) When the cause of dizziness is found to be an organic central disease F) When the cause of dizziness is found to be other vestibular diseases such as vestibular neuritis and Meniere's diseaseG) When dizziness and nystagmus were improved during the series of procedures based on this study H) In the investigator's opinion, subjects are difficult to participate I) Subjects who disagree with this clinical trial.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	immediately effects of canalith repositioning procedures (CRP)
Timepoint	one or two hour after treatment
Secondary Outcome(s) 1
Outcome	long term effects of CRP
Timepoint	a week after treatement
Secondary Outcome(s) 2
Outcome	Dizziness Handicap Inventory score,
Timepoint	a week after treatement
Secondary Outcome(s) 3
Outcome	Treatment effect according to underlying medical history, sex, and age.
Timepoint	a week after treatement

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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