UMIN-CTR Clinical Trial

Public title

Construction of a diagnostic aid system for Werner syndrome using voice data

Acronym

Construction of a diagnostic aid system for Werner syndrome using voice data

Scientific Title

Construction of a diagnostic aid system for Werner syndrome using voice data

Scientific Title:Acronym

Construction of a diagnostic aid system for Werner syndrome using voice data

Region

Japan

Condition

Werner syndrome

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Werner syndrome, an inherited premature aging disorder, causes various symptoms from puberty onward, and death occurs in the 50-60 age group due to malignancy and atherosclerosis. Although the onset of the disease is estimated to be in the 20s, the actual diagnosis is made at around 40 years of age. By the time symptoms appear and the disease is diagnosed, the condition is frequently complicated by the progression of sarcopenia, infection due to intractable skin ulcers, and amputation of lower limbs. To provide early preventive and therapeutic intervention for the various symptoms of this disease, there is a need to develop a method to aid in early diagnosis. The diagnostic criteria for this disease include a distinctive, abnormal voice called harmonic hoarseness, which is frequently observed, but no objective index or evaluation method has been established. Therefore, we will collect data on the characteristic voice of this disease and objectively evaluate the difference between normal subjects and other diseases that cause hoarseness. In addition, through joint research with the Department of Otorhinolaryngology, we will determine the organic characteristics and hearing ability of patients with this disease and use this as a stepping stone to elucidate the mechanism of this disease's characteristic voice and make a diagnosis.

Basic objectives2

Others

Basic objectives -Others

We focused on Jitter, an objective measure of abnormal voice, as the primary endpoint. In addition, the presence of morphological changes is quantified and evaluated objectively in collaboration with the Department of Otorhinolaryngology.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Differences from the physician's subjective diagnostic establishment of hoarseness (80%); does Jitter show abnormal values in more than 80% of cases?"
The voice data will be analyzed, its characteristics and features will be determined, and the above will be compared between two groups, Werner syndrome and normal subjects.

Jitter (primary periodic fluctuation index) is a parameter of the disturbance of vocal fold vibration cycles. It is calculated by dividing the average difference between adjacent cycles' cycles by the average value of the overall cycle. The larger the value, the more frequent the grazing, but it has been reported to be an objective and reproducible indicator of hoarseness. Among the primary endpoints of the diagnostic criteria for this disease, abnormal voice, which is judged subjectively by the physician, is found in more than 80% of cases. Therefore, we hypothesized that Jitter, an objective index, may show abnormal values in more than 80% of cases and aimed to examine whether Jitter abnormalities could be a diagnostic aid in diagnosing this disease.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Speech and continuous vowel speech data of Werner syndrome patients who agree to participate in the study reading specific scripts will be recorded and coded. The data will be coded and analyzed by an outside research institute and compared in two groups: Werner syndrome cases and a control group.
In addition, vocal cord evaluation and voice assessment measures involved in voice disorders (laryngoscopy, stroboscopy, subjective voice evaluation (VHI), auditory psychological evaluation (GRBAS), vocal function testing, acoustic analysis, and audiometry) will be evaluated by an otolaryngologist.

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects will be cases who are attending or hospitalized at Chiba University Hospital, as well as cases requested by other hospitals or the patients themselves, and who, with their consent, can make voice recordings and provide voice data on Werner syndrome, suspected cases, and blood-related family members. As a negative control, voice data from patients with diseases other than Werner syndrome and healthy individuals will also be included. However, existing voice data other than those for Werner syndrome will be used instead of acquiring new voice data. For this reason, we will use speech data from publicly available databases and a textbook on speech disorders published by the Japanese Association of Speech-Language Pathologists to compare speech sounds with those of normal subjects and those of other diseases that cause hoarseness.

Key exclusion criteria

Those who could not give consent

Target sample size

12

Name of lead principal investigator

1st name	Yoshiro
Middle name
Last name	Maezawa

Organization

Chiba University Graduate School of Medicine

Division name

Department of Endocrinology, Hematology and Gerontology

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku,Chiba

TEL

0432227171

Email

yoshiromaezawa@chiba-u.jp

Name of contact person

1st name	Masaya
Middle name
Last name	Koshizaka

Organization

Chiba University

Division name

Center for Preventive Medical Sciences

Zip code

263-8522

Address

1-33, Yayoicho, Inage-ku, Chiba-shi, Chiba

TEL

043-251-1111

Homepage URL

Email

overslope@chiba-u.jp

Institute

Department of Endocrinology, Hematology and Gerontology
Chiba University Graduate School of Medicine

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba University Hospital, Clinical Research Center

Address

1-8-1 Inohana, Chuo-ku,Chiba

Tel

043-226-2734

Email

prc-jim@chiba-u.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

06

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

04

Month

26

Day

Date of IRB

2023

Year

12

Month

18

Day

Anticipated trial start date

2024

Year

04

Month

26

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

06

Month

24

Day

Last modified on

2025

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062559