UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053283 |
|---|---|
| Receipt number | R000060814 |
| Scientific Title | Evaluation Study of Biorhythms in Sleep Apnea Syndrome |
| Date of disclosure of the study information | 2024/02/29 |
| Last modified on | 2024/01/11 15:05:32 |
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Basic information
Public title
Evaluation Study of Biorhythms in Sleep Apnea Syndrome
Acronym
Evaluation Study of Biorhythms in Sleep Apnea Syndrome
Scientific Title
Evaluation Study of Biorhythms in Sleep Apnea Syndrome
Scientific Title:Acronym
Evaluation Study of Biorhythms in Sleep Apnea Syndrome
Region
| Japan |
Condition
Condition
Sleep Apnea Syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our circadian rhythm is regulated by our body clock and is involved in the sleep-wake cycle, blood pressure, body temperature, hormone secretion, and other fluctuations, and is an essential part of our life activities. Disruption of the circadian rhythm is said to lead to obesity and lifestyle-related diseases. In particular, disruption of the sleep rhythm is likely to lead to various subjective physical ailments and complications of the body. In addition, since sleep state varies with sleep-disordered breathing such as sleep apnea syndrome, gender, age, and other factors, evaluation of changes in each of these states is likely to lead to clarification of pathological conditions and causes of physical ailments. In this study, we aim to evaluate the changes that occur during sleep by assessing the biorhythms that change in the body during nighttime sleep.
Basic objectives2
Others
Basic objectives -Others
Skin resistance is evaluated at the same time as all-night polysomnography for diagnostic purposes in patients with sleep apnea or suspected sleep apnea.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin Resistance Changes
Key secondary outcomes
Sleep stages, vital signs, ECG, respiratory status, pulse oximeter, etc. obtained from PSG testing equipment
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
One test, wearing the device for 5 to 8 hours at bedtime
Interventions/Control_2
Skin resistance measurement device is fitted
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with sleep apnea or suspected sleep apnea
Key exclusion criteria
1) Persons with serious skin diseases at the test site
2) Persons with serious cardiac or muscular system diseases.
3) Persons with metal allergies.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Fukunaga |
Organization
Department of Medicine, Keio University, School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
wakako.y@keio.jp
Public contact
Name of contact person
| 1st name | Wakako |
| Middle name | |
| Last name | Yamasawa |
Organization
Department of Medicine, Keio University, School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
Homepage URL
wakako.y@keio.jp
Sponsor or person
Institute
Department of Medicine, Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Someya Laboratory, Department of Electrical Engineering, Graduate School of Engineering, The University of Tokyo
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
none
Address
none
Tel
none
none
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 29 | 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
| 2024 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060814
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| Registered date | File name |
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