UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040190 |
|---|---|
| Receipt number | R000045827 |
| Scientific Title | High flow nasal cannula on sleep apnea syndrome in stroke patients |
| Date of disclosure of the study information | 2020/04/19 |
| Last modified on | 2020/08/27 09:40:39 |
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Basic information
Public title
High flow nasal cannula on sleep apnea syndrome in stroke patients
Acronym
High flow nasal cannula on sleep apnea syndrome in stroke patients
Scientific Title
High flow nasal cannula on sleep apnea syndrome in stroke patients
Scientific Title:Acronym
High flow nasal cannula on sleep apnea syndrome in stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
High flow nasal cannula on sleep apnea syndrome in stroke patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep efficiency, Rem sleep, Apnea-hypopnea index, Oxygen desaturation index
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke
Key exclusion criteria
SAS with suspected other conditions (neuromuscular disease, heat failure, and narcolepsy), past history of SAS, catecholamine use which may affect the vascular tone, patients having unsuccessful recording in any WatchPat channel.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima
TEL
088-633-9347
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
2-50-1 Kuramoto, Tokushima
TEL
088-633-9347
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical Trial Center for Developmental therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto, Tokushima
Tel
088-633-9294
awachiken@tokushima-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
| 2020 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32832300/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32832300/
Number of participants that the trial has enrolled
12
Results
There were no differences in sleep-disordered breathing and sleep quality with and without HFNC therapy as follows: HFNC therapy vs control: apnea-hypopnea index 24.9 vs 21.3/h (p = 0.63), oxygen desaturation index 16.2 vs 12.9/h (p = 0.54), sleep efficiency 80.4 vs 87.1 (p = 0.28), percentage of REM sleep 19.4% vs 27.6% (p = 0.07). Two patients (17%) complained of discomfort among eight patients.
Results date posted
| 2020 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 25 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 04 | Month | 18 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045827
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
