UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035577 |
|---|---|
| Receipt number | R000040536 |
| Scientific Title | Prospective analyses of effects of head positions on apnea-hypopnea index in obstructive sleep apnea patients |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2020/11/05 22:07:10 |
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Basic information
Public title
Prospective analyses of effects of head positions on apnea-hypopnea index in obstructive sleep apnea patients
Acronym
Effects of head positions on AHI in OSA patients
Scientific Title
Prospective analyses of effects of head positions on apnea-hypopnea index in obstructive sleep apnea patients
Scientific Title:Acronym
Effects of head positions on AHI in OSA patients
Region
| Japan |
Condition
Condition
Obstructive Sleep Apnea Syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective single institutional study is designed to analyze effects of head positions on apnea-hypopnea index (AHI) by measuring head and body positions simultaneously with full polysomnography (PSG).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analyze effects of head positions on AHI
Key secondary outcomes
1)Effects of body weight, neck circumference and abdominal circumference on phase differences between head and body positions
2)Effects of body positions on AHI
3)Relationships between sleep stages and AHI alteration induced by head and body positions
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
Patients suspected with OSA who were admitted to the Sleep Center of Tokai University Hospital (Isehara, Japan)
Key exclusion criteria
Patients less than 20 years old are excluded.
Patients who are considered as inappropriate for this study by the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Aoki |
Organization
The Sleep Center of Tokai University Hospital
Division name
Respiratory Division, Department of Internal Medicine, Tokai University School of Medicine
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
aokitaku@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Aoki |
Organization
The Sleep Center of Tokai University Hospital
Division name
Respiratory Division, Department of Internal Medicine, Tokai University School of Medicine
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
Homepage URL
aokitaku@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Sleep Center of Tokai University Hospital
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
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
| 2019 | Year | 01 | Month | 23 | 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
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Termination of this observational study
Management information
Registered date
| 2019 | Year | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040536
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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