UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018713 |
|---|---|
| Receipt number | R000021310 |
| Scientific Title | Pathophysiological analysis of sleep-disordered breathing toward building the individualized treatment |
| Date of disclosure of the study information | 2015/08/20 |
| Last modified on | 2021/09/17 08:36:27 |
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Basic information
Public title
Pathophysiological analysis of sleep-disordered breathing toward building the individualized treatment
Acronym
Pathophysical analysis study of sleep-disordered breathing(Pathophysiological SDB study)
Scientific Title
Pathophysiological analysis of sleep-disordered breathing toward building the individualized treatment
Scientific Title:Acronym
Pathophysical analysis study of sleep-disordered breathing(Pathophysiological SDB study)
Region
| Japan |
Condition
Condition
Sleep-disordered breathing
Classification by specialty
| Pneumology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the feasibility and effectiveness of the treatment according to the pathophysiological evaluation of upper airway collapsibility, stability of breathing and arousability.
Basic objectives2
Others
Basic objectives -Others
Human study to analyze the pathophysiology of SDB
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ventilatory response (ventilation, respiratory rate, arousal timing) to compute upper airway collapsibility,
unstable control of breathing and arousability on the experimental day.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Repeated dial-down and dial-up of continuous positive airway pressure (CPAP) to see respiratory response to the intervention of several different level.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Obstructive sleep apnea patients who are during treatment
Key exclusion criteria
1. Unstable comorbidity
2. Respiratory failure
3. Renal failure on hemodialysis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Nakayama |
Organization
Tokyo Medical University
Division name
Department of Respiratory Medicine
Zip code
Address
6-7-1 Nishi-shinjuku, Shinjuku-ku, TOKYO
TEL
03-3342-6111
hidenaka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Nakayama |
Organization
Tokyo Medical University
Division name
Department of Respiratory Medicine
Zip code
Address
6-7-1 Nishi-shinjuku, Shinjuku-ku, TOKYO
TEL
03-3342-6111
Homepage URL
hidenaka@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 08 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Twenty eight cases were enrolled until March, 2018.
Management information
Registered date
| 2015 | Year | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021310
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/08/19 | 病態SDB研究計画書ver. 4.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
