UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055532 |
|---|---|
| Receipt number | R000061972 |
| Scientific Title | Observational study on mitochondrial hearing loss. |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/09/18 15:36:53 |
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Basic information
Public title
Observational study on mitochondrial hearing loss.
Acronym
Observational study on mitochondrial hearing loss.
Scientific Title
Observational study on mitochondrial hearing loss.
Scientific Title:Acronym
Observational study on mitochondrial hearing loss.
Region
| Japan |
Condition
Condition
mitochondrial hearing loss
Classification by specialty
| Medicine in general | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess hearing loss progression in mitochondrial disease patients with hearing loss by measuring hearing with ABR testing, ASSR testing, standard pure-tone audiometry, and DPOAE.
Basic objectives2
Others
Basic objectives -Others
To determine auditory changes in patients with mitochondrial disease with hearing loss during the observation period.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
When subjects attend for routine medical care, their hearing is measured with the ABR test for cerebral auditory response, the ASSR test for auditory steady-state response, standard pure tone audiometry and the DPOAE test for otoacoustic emissions (DPOAE) and is assessed for changes in hearing during the observation period.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects with an overall confirmed diagnosis of MELAS or MELA (mtDNA 3243 mutation) based on clinical findings, myopathology, and genetic testing according to the diagnostic criteria for MELAS.
2. Subjects diagnosed with mitochondrial deafness
3. Subjects aged between 16 and 59 years at the time of consent
4. Subjects who have given informed written consent. However, if the patient is a minor, the free and voluntary written consent must be obtained from a surrogate.
Key exclusion criteria
1. Subjects with cognitive impairment who, in the opinion of the investigator or sub-investigator, may have difficulty with JMDRS or NMDPS/NMDAS scoring.
2. Subjects with concomitant hearing loss due to causes other than mitochondrial disease
3. Subjects with cochlear implants
4. Subjects with severe hearing loss
5. Subjects on a respirator
6. Subjects with epileptic seizures (convulsions) and severe coma
7. Subjects with septic complications
8. Subjects with renal impairment (estimated glomerular filtration rate eGFR less than 30 mL/min/1.73 m2).
9. Subjects who have participated in other clinical trials within 6 months prior to consent.
Other subjects deemed inappropriate by the principal investigator or sub-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Abe |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Division of Medical Science
Zip code
980-8574
Address
1-1 Seiryo-Machi, Aoba-Ward, Sendai, Miyagi, Japan.
TEL
022-717-7200
mitomoonshot@grp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Abe |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Division of Medical Science
Zip code
980-8574
Address
1-1 Seiryo-Machi, Aoba-Ward, Sendai, Miyagi, Japan.
TEL
022-717-7200
Homepage URL
mitomoonshot@grp.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-Machi, Aoba-Ward, Sendai, Miyagi, Japan.
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2024 | Year | 10 | 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
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2024 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061972
