UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046793 |
|---|---|
| Receipt number | R000048101 |
| Scientific Title | Exploratory clinical trial of rehabilitation using olfactory rehabilitation equipment for persons with olfactory dysfunction after laryngectomy |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2025/01/23 14:44:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effect of rehabilitation using olfactory rehabilitation equipment for olfactory impaired persons after laryngectomy
Acronym
Olfactory rehabilitation for people with olfactory dysfunction after laryngectomy
Scientific Title
Exploratory clinical trial of rehabilitation using olfactory rehabilitation equipment for persons with olfactory dysfunction after laryngectomy
Scientific Title:Acronym
Exploratory clinical trials of rehabilitation using olfactory rehabilitation equipment
Region
| Japan |
Condition
Condition
Laryngeal cancer
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of olfactory rehabilitation on olfactory disorders after laryngectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Olfactory test 0,1,3,6,12months later
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Practice every day for about 5 minutes
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients whose larynx has been removed due to a disease of the throat or esophagus
(2) Patients who fully understand this research plan and can give their consent
(3) Patients who are 20 years of age or older at the time of obtaining consent
(4) Within 6 months after surgery
Key exclusion criteria
(1) Patients who did not wish for olfactory rehabilitation
(2) Other patients who the researcher judges to be inappropriate as research subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Otorhinolaryngology
Zip code
812-8582
Address
3-1-1Maidashi Higashi-ku Fukuoka
TEL
092-642-5668
yamaguchi.yumi.764@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Otorhinolaryngology
Zip code
812-8582
Address
3-1-1Maidashi Higashi-ku Fukuoka
TEL
092-642-5668
Homepage URL
yamaguchi.yumi.764@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University.
Institute
Department
Personal name
Funding Source
Organization
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University.
Address
3-1-1Maidashi Higashi-ku Fukuoka
Tel
092-642-5668
yamaguchi.yumi.764@m.kyushu-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
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048101
