UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038127 |
|---|---|
| Receipt number | R000043455 |
| Scientific Title | Development of a new sleep apnea diagnostic method using intravenous sedation |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2021/09/28 09:10:46 |
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Basic information
Public title
Development of a new sleep apnea diagnostic method using intravenous sedation
Acronym
Development of a new sleep apnea diagnostic method using intravenous sedation
Scientific Title
Development of a new sleep apnea diagnostic method using intravenous sedation
Scientific Title:Acronym
Development of a new sleep apnea diagnostic method using intravenous sedation
Region
| Japan |
Condition
Condition
intravenous sedation
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During the management of intravenous sedation, upper airway obstruction is likely to occur, and this pathology is similar to the mechanism of maintaining upper airway patency during sleep, applying a new sleep apnea upper airway patency The aim is to develop a diagnosis of.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
upper airway patency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
propofol
Interventions/Control_2
dexmedetomidine
Interventions/Control_3
ketamine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult subjects who agreed to the study
Key exclusion criteria
Patients with serious systemic complications
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TAKAO |
| Middle name | |
| Last name | AYUSE |
Organization
Nagasaki University
Division name
Dental Anesthesia
Zip code
8528588
Address
1-7-1 Sakamoto Nagasaki
TEL
0958197713
ayuse@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKAO |
| Middle name | |
| Last name | AYUSE |
Organization
Nagasaki University Hospital
Division name
Dental Anesthesia
Zip code
8528588
Address
1-7-1 Sakamoto Nagasaki
TEL
0958197713
Homepage URL
ayuse@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Nagasaki University
Address
1-7-1 Sakamto
Tel
0958197198
t-nakao@nagasaki-u.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
| 2019 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043455
