UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040190
Receipt No. 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 (Ver. 3)

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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
Email 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
Email nobuto_nakanishi@yahoo.co.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045827