UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047112 |
|---|---|
| Receipt number | R000053174 |
| Scientific Title | Analysis of the relationship between the various parameters of decrease of SpO2 and blood pressure and the fluctuation of blood pressure measured by PTT in the patients of OSAS. |
| Date of disclosure of the study information | 2022/03/08 |
| Last modified on | 2024/03/13 09:46:44 |
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Basic information
Public title
Analysis of the relationship between decrease of SpO2 and blood pressure and the fluctuation in the patients of OSAS.
Acronym
PTT-OSAS study
Scientific Title
Analysis of the relationship between the various parameters of decrease of SpO2 and blood pressure and the fluctuation of blood pressure measured by PTT in the patients of OSAS.
Scientific Title:Acronym
PTT-OSAS study
Region
| Japan |
Condition
Condition
Sleep Apnea Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between "PTT blood pressure and the fluctuation of BP" and "the various parameters including decrease of SpO2 measured by PSG and Somno touch Resp", in patients diagnosed with OSAS (apnea-hypopnea index>5/h).
Basic objectives2
Others
Basic objectives -Others
To examine the relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 The relationship between delta SBP/delta SpO2 and the parameters obtained by PSG above and below the threshold of the point of initiation of elevation of PTT-BP.
2 Relationship between the gain between SpO2 and PTT-SBP fluctuation obtained using the frequency analysis in 0.01-0.05Hz.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with OSAS(AHI>5/h) by Polysomnography.
(2) Patients whose PTT blood pressure is measured by SomnoTouch Resp.
(3) 20 and 80 years of age
Key exclusion criteria
(1) Patients who have poor control of tachycardia attacks, hypertension, and heart failure and are judged by the investigator to be inappropriate to perform the test.
(2) Patients who are considered to have difficulty in measuring pulse transit time (having a shunt due to dialysis or having arterial occlusion in the limb)
(3) Patients whose sleep status at the time of PTT measurement is judged to deviate significantly from normal sleep habits (heavy drinking, extremely short sleep time)
(4) Patients who are inappropriate to attend this study judged by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Hosokawa |
Organization
Kyushu University Hospital
Division name
Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, maidashi, Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-642-5360
hosokawa.kazuya.712@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Yoshioka |
Organization
Fukuokaken Saiseikai Futsukaichi Hospital
Division name
Sleep Medical Center
Zip code
812-8582
Address
3-13-1, Yu-machi, Chikushino-shi, Fukuoka
TEL
092-923-1551
Homepage URL
yoshioka.yasuko@junnai.org
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu 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
Kyushu University Institutional Review Board for Clinical Research
Address
3-1-1, maidashi, higashi-ku, Fukuoka
Tel
092-642-6254
ijkseimei@jimu.kyushu-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
| 2022 | Year | 03 | Month | 08 | 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
145
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2022 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053174
