UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045900 |
|---|---|
| Receipt number | R000052401 |
| Scientific Title | Swallowing pattern during sleeping in stroke patients with suspected obstructive sleep apnea |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2021/10/28 17:03:24 |
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Basic information
Public title
Swallowing pattern during sleeping in stroke patients with suspected obstructive sleep apnea
Acronym
Swallowing pattern in patients with suspected OSA
Scientific Title
Swallowing pattern during sleeping in stroke patients with suspected obstructive sleep apnea
Scientific Title:Acronym
SPOSA
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the changes in respiration and swallowing during sleeping in stroke patients with suspected sleep apnea syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swallowing pattern during sleeping
Key secondary outcomes
EAT-10, modified water swallowing test, repetitive saliva swallowing test, 3 oz water swallowing test, rhinomanometry, and polysomnography
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 patients who are planned polysomnography
Key exclusion criteria
Unstable patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Hirata |
Organization
Fujita Health University Bantane Hospital
Division name
Department of Clinical Laboratory
Zip code
454-8509
Address
3-6-10, Otobashi, Nakagawa-ku, Nagoya-shi, Aichi
TEL
052-321-8171
mthirata@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Hirata |
Organization
Fujita Health University Bantane Hospital
Division name
Department of Clinical Laboratory
Zip code
454-8509
Address
3-6-10, Otobashi, Nakagawa-ku, Nagoya-shi, Aichi
TEL
052-321-8171
Homepage URL
mthirata@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology and Sleep Medicine, School of Medicine, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2021 | Year | 10 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the swallowing pattern during sleeping by screening tests for swallowing function, rhinomanometry, polysomnography, and surface electromyography in swallow related muscles.
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052401
