UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035611 |
|---|---|
| Receipt number | R000040571 |
| Scientific Title | The randomized clinical trial for determination the head position of that interval time does not need during Epley maneuver |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2024/11/07 16:49:31 |
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Basic information
Public title
The randomized clinical trial for determination the head position of that interval time does not need during Epley maneuver
Acronym
Interval time during Epley maneuver
Scientific Title
The randomized clinical trial for determination the head position of that interval time does not need during Epley maneuver
Scientific Title:Acronym
Interval time during Epley maneuver
Region
| Japan |
Condition
Condition
benign paroxysmal positional vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find the head position of that interval time does not need during Epley maneuver
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum slow phase eye velocity of positional nystagmus
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The interval time of first head position during Epley maneuver sets to be 10 minutes.
Interventions/Control_2
The interval time of third head position during Epley maneuver sets to be 10 minutes.
Interventions/Control_3
The interval time of fourth head position during Epley maneuver sets to be 10 minutes.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are strongly suspected to exhibit BPPV by medical interview.
Key exclusion criteria
Patients who have lumber and/or cervical spine disease. The pregnant. Patients who can not be obtained their consent.
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi
TEL
06-6879-3951
timai@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
Suita-shi
TEL
06-6879-3951
Homepage URL
timai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Osaka University Graduate School of Medicine
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Graduate School of Medicine
Address
2-2 Yamadaoka, Suita-shi
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.med.osaka-u.ac.jp/pub/ent/speciality/files/cr_deafness190117.pdf
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00405-024-08831-6
Number of participants that the trial has enrolled
51
Results
Fifty-one patients with posterior canal type of benign paroxysmal positional vertigo were randomly assigned to the following three groups: 10 min interval time set at the first head position of the Epley maneuver in group A, at the third head position in group B, and at the fourth head position in group C. The immediate effect of the Epley maneuver in group A was best.
Results date posted
| 2024 | Year | 11 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with posterior canal type of benign paroxysmal positional vertigo
Participant flow
Patients who were suspected of having posterior canal type of benign paroxysmal positional vertigo based on interview were enrolled in the primary registration and randomly divided into three groups. Patients who were diagnosed with posterior canal type of benign paroxysmal positional vertigo were enrolled in the secondary registration and underwent the Epley maneuver according to the group they were assigned to.
Adverse events
Two patients experienced nausea during the Epley maneuver.
Outcome measures
The primary outcome measure was the ratio of MSPEV of positional nystagmus in the second Dix-Hallpike test compared with that of the first Dix-Hallpike test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040571
