UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048229 |
|---|---|
| Receipt number | R000054954 |
| Scientific Title | Epidemiological studies on the relationship between age, sensorineural hearing loss, and the distribution of blood NAD+ levels |
| Date of disclosure of the study information | 2022/07/02 |
| Last modified on | 2025/01/16 12:03:41 |
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Basic information
Public title
Epidemiological studies on the relationship between age, sensorineural hearing loss, and the distribution of blood NAD+ levels
Acronym
Epidemiological studies on the relationship between age, sensorineural hearing loss, and the distribution of blood NAD+ levels
Scientific Title
Epidemiological studies on the relationship between age, sensorineural hearing loss, and the distribution of blood NAD+ levels
Scientific Title:Acronym
Epidemiological studies on the relationship between age, sensorineural hearing loss, and the distribution of blood NAD+ levels
Region
| Japan |
Condition
Condition
sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the distribution of blood NAD+ level according to age and presence of sensorineural hearing loss such as age-related hearing loss and sudden hearing loss.
Basic objectives2
Others
Basic objectives -Others
Epidemiological survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood NAD+ levels in healthy subjects without hearing loss in 50s, in patients with sudden hearing loss (unilateral severe) in 50s, in patients with bilateral severe and advanced hearing loss in 80 years of age and older, and in patients without bilateral severe and advanced hearing loss in 80 years of age and older.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy person without hearing loss in 50s
(2) Patients in 50s with sudden hearing loss (unilateral severe)
3) Patients in 80 years of age and older with bilateral severe or profound hearing loss
4) Patients in 80 years of age and older with no bilateral severe or profound hearing loss
5) Patients who can abstain from food in the morning and can visit the clinic in the morning.
(6) Patients who give consent to participate in the study.
Key exclusion criteria
(1) Patients with hearing loss due to factors unrelated to aging, such as trauma or hearing loss due to complications from other diseases
(2) Patients taking nicotinamide mononucleotide (NMN)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakata |
Organization
Kawagoe Otology Institute
Division name
Division of Otorhinolaryngology
Zip code
350-1122
Address
Kawagoe Ear Institute, Division of Otorhinolaryngology, Kawagoe Mine Medical Center, 103 Wakitacho, Kawagoe, Saitama
TEL
049-226-3387
sakata@jikagaku.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakata |
Organization
Kawagoe Otology Institute
Division name
Division of Otorhinolaryngology
Zip code
350-1122
Address
Kawagoe Ear Institute, Division of Otorhinolaryngology, Kawagoe Mine Medical Center, 103 Wakitacho,
TEL
049-226-3387
Homepage URL
sakata@jikagaku.jp
Sponsor or person
Institute
Kawagoe Otology Institute,Division of Otorhinolaryngology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The clinical research ethical review board of Shido. Inc.
Address
614, 3-13-2 Kameari, Katsushika-ku, Tokyo
Tel
03-4500-5075
info@shido.co.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 | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jocmr.elmerjournals.com/jocmr/article/view/6083/73
Number of participants that the trial has enrolled
80
Results
Decreased amount of NAD+ in the body and increased dROMs levels were associated with increased risk of developing SNHL, and the development of ARHL was especially highly associated with a decreased amount of NAD+ in the body.
Results date posted
| 2025 | Year | 01 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Currently in the process of submitting a paper.
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 28 | Day |
Baseline Characteristics
A single-center, observational study at Kawagoe Otology Institute in Japan
The sample size is 80 patients. In 4 groups of 20 patients each: patients aged 50-79 years with or without unilateral sudden sensorineural hearing loss (SSNHL), and patients aged over 80 years with or without bilateral age-related hearing loss (ARHL).
The distribution of whole-blood NAD+ levels was investigated. We also measured oxidative stress markers (diacron-reactive oxygen metabolites [dROMs] and biological antioxidant potential [BAP]) and examined the relationship between the development of SNHL and whole blood NAD+ levels, dROMs, and BAP.
Participant flow
Adverse events
Outcome measures
The primary endpoints were the difference in whole-blood NAD+ levels between those aged 50-79 years without hearing loss and those aged 50-79 years with SSNHL (unilateral, severe), and the difference in whole-blood NAD+ levels between those aged over 80 years without bilateral hearing loss and those aged over 80 years with bilateral SNHL. In addition, correlations among factors associated with the development of hearing loss and laboratory test values were analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Observational Study
Management information
Registered date
| 2022 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054954
