UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060487 |
|---|---|
| Receipt number | R000069196 |
| Scientific Title | "Clinical significance of non-contact vital signs monitoring in children with eating disorders: an exploratory prospective study" |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/27 16:28:24 |
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Basic information
Public title
"Clinical significance of non-contact vital signs monitoring in children
with eating disorders: an exploratory prospective study"
Acronym
"Clinical significance of non-contact vital signs monitoring in children
with eating disorders: an exploratory prospective study"
Scientific Title
"Clinical significance of non-contact vital signs monitoring in children
with eating disorders: an exploratory prospective study"
Scientific Title:Acronym
"Clinical significance of non-contact vital signs monitoring in children
with eating disorders: an exploratory prospective study"
Region
| Japan |
Condition
Condition
eating disorder(anorexia nervosa,avoidant/restrictive food intake disorder)
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"The purpose of this study is to evaluate the relationship between changes in thyroid hormone levels (FT3) and changes in physical changes (weight, heart rate) measured by non-contact vital signs monitoring during the course from the start of renutrition through hospitalization to discharge in 10 children with anorexia nervosa and avoidant/restrictive food intake disorder.
Comparisons will be made with pediatric inpatients without eating disorders (control group of 10)."
Basic objectives2
Others
Basic objectives -Others
Analyze the differences in patterns of change in FT3, weight, heart rate, breathing, etc. depending on the different treatment periods.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum free triiodothyronine (FT3) levels
Key secondary outcomes
"Body mass index standard deviation score (BMI-SDS) calculated from body weight measured using both conventional scales and a non-contact vital signs monitoring
Pulse rates measured by nurses, patient monitoring devices, Holter electrocardiography, and a non-contact vital signs monitoring."
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients who exhibited poor weight gain or weight loss during a defined period prior to admission.
(2)Patients who were able to communicate with medical staff (e.g., physicians and nurses) and deemed capable of continuing inpatient treatment.
(3) Patients for whom parental consent was obtained and whose own intent could be confirmed."
Key exclusion criteria
(1) Patients aged 6 to 17 years (corresponding to Japanese elementary school grade 1 through high school grade 3) diagnosed with anorexia nervosa or avoidant/restrictive food intake disorder, who did not exhibit poor weight gain or weight loss due to prior inpatient or outpatient treatment.
(2)Patients deemed unsuitable for participation in this study by the principal investigator."
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | YUKI |
| Middle name | |
| Last name | SUZUKI |
Organization
Department of Pediatrics, National Hospital Organization Mie National Hospital
Division name
Pediatrics
Zip code
514-0125
Address
357,Oosato Kubota-tyou,Tsu city,Mie,JAPAN
TEL
059-232-2531
lemonhaichu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | SUZUKI |
Organization
Department of Pediatrics, National Hospital Organization Mie National Hospital
Division name
Pediatrics
Zip code
514-0125
Address
357,Oosato Kubota-tyou,Tsu city,Mie,JAPAN
TEL
059-232-2531
Homepage URL
lemonhaichu@yahoo.co.jp
Sponsor or person
Institute
Department of Pediatrics, National Hospital Organization Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
other
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 Pediatrics, National Hospital Organization Mie National Hospital
Address
357,Oosato Kubota-tyou,Tsu city,Mie,JAPAN
Tel
0592322531
315-kanrika@mail.hosp.go.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
| 2026 | 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
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"The purpose of this study is to evaluate the relationship between changes in thyroid hormone levels (FT3) and changes in physical changes (weight, heart rate) measured by non-contact vital signs monitoring during the course from the start of renutrition through hospitalization to discharge in 10 children with anorexia nervosa and avoidant/restrictive food intake disorder.
Comparisons will be made with pediatric inpatients without eating disorders (control group of 10)."
Primary outcomes:Serum free triiodothyronine (FT3) levels
Key secondary outcomes:"Body mass index standard deviation score (BMI-SDS) calculated from body weight measured using both conventional scales and a non-contact vital signs monitoring
Pulse rates measured by nurses, patient monitoring devices, Holter electrocardiography, and a non-contact vital signs monitoring."
Control:10 inpatient children without eating disorders
age:6~18years old
Key inclusion criteria:(1)Patients who exhibited poor weight gain or weight loss during a defined period prior to admission.
(2)Patients who were able to communicate with medical staff (e.g., physicians and nurses) and deemed capable of continuing inpatient treatment.
(3) Patients for whom parental consent was obtained and whose own intent could be confirmed.
Key exclusion criteria:"(1) Patients aged 6 to 17 years (corresponding to Japanese elementary school grade 1 through high school grade 3) diagnosed with anorexia nervosa or avoidant/restrictive food intake disorder, who did not exhibit poor weight gain or weight loss due to prior inpatient or outpatient treatment.
(2)Patients deemed unsuitable for participation in this study by the principal investigator."
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069196
