UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050307 |
|---|---|
| Receipt number | R000057283 |
| Scientific Title | A detection of adrenal deficiency through the use of Ecological Momentary Assessment and IoT technology |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2025/02/12 19:54:47 |
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Basic information
Public title
A detection of adrenal deficiency through the use of Ecological Momentary Assessment and IoT technology
Acronym
A detection of adrenal deficiency through the use of EMA and IoT technology
Scientific Title
A detection of adrenal deficiency through the use of Ecological Momentary Assessment and IoT technology
Scientific Title:Acronym
A detection of adrenal deficiency through the use of EMA and IoT technology
Region
| Japan |
Condition
Condition
Adrenocortical insufficiency, Adrenal insufficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the correlation between physical activity readings obtained through the combination of Ecological Momentary Assessment and IoT technology, and a indication of adrenal insufficiency.
Basic objectives2
Others
Basic objectives -Others
To examine and assess the correlation between cortisol levels in saliva, depressive mood assessed through a 14-day Ecological Momentary Assessment, and physical activity readings captured by a 14-day wearable medical device.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
An examination of cortisol levels in saliva and the correlation between physical activity data (such as depressive mood, sleep duration, body temperature, and pulse rates) gathered through the utilization of Ecological Momentary Assessment and IoT technology
Key secondary outcomes
The correlation between changes in physical activity readings on a daily basis and cortisol levels in saliva
Assessment of the relevance of physical activity readings, cortisol levels in saliva, profile data, questionnaire responses, and medical records
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Patient Group:
1.Individuals with adrenocortical insufficiency undergoing hydrocortisone treatment exceeding 15mg per day
2.Individuals who possess a smartphone and are able to respond to questionnaires
3.Individuals able to wear a ring medical device and provide saliva samples
4.Individuals who have provided written informed consent
Control Group:
1.Healthy individuals who possess a smartphone and are able to respond to questionnaires
2.Individuals able to wear a ring medical device and provide saliva samples
3.Individuals who have provided written informed consent
Key exclusion criteria
1.Individuals who are unable to sleep while wearing a ring medical device
2.Individuals who are unable to utilize the study app
3.Individuals deemed inappropriate to participate in the study by physician judgement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Aika |
| Middle name | |
| Last name | Miya |
Organization
Hokkaido University Hospital
Division name
Diabetes and Endocrinology
Zip code
060-8638
Address
N15W7, Kita-ku, Sapporo , Japan
TEL
+81-11-706-5915
miyaaika@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Aika |
| Middle name | |
| Last name | Miya |
Organization
Hokkaido University Hospital
Division name
Diabetes and Endocrinology
Zip code
060-8638
Address
N15W7, Kita-ku, Sapporo, Japan
TEL
+81-11-706-5915
Homepage URL
miyaaika@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2023 | Year | 02 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study involving healthy male participants and male patients diagnosed with adrenal insufficiency.
Management information
Registered date
| 2023 | Year | 02 | Month | 11 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057283
