UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016600 |
|---|---|
| Receipt number | R000019255 |
| Scientific Title | Estimating the severity of obstructive sleep apnea syndrome by measuring the areas of upper airway on magnetic resonance imaging |
| Date of disclosure of the study information | 2015/02/22 |
| Last modified on | 2015/02/22 15:49:57 |
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Basic information
Public title
Estimating the severity of obstructive sleep apnea syndrome by measuring the areas of upper airway on magnetic resonance imaging
Acronym
Estimating the severity of OSAS by measuring the areas of upper airway on MRI
Scientific Title
Estimating the severity of obstructive sleep apnea syndrome by measuring the areas of upper airway on magnetic resonance imaging
Scientific Title:Acronym
Estimating the severity of OSAS by measuring the areas of upper airway on MRI
Region
| Japan |
Condition
Condition
obstructive sleep apnea syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure upper airway, for example, the areas of the velopharynx (VP), oropharynx (OP), and hypopharynx (HP) using magnetic resonance imaging (MRI) and investigate the associations between those areas and the severity of OSAS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The apnea-hypopnea index (AHI) measuring by simple PSG. The areas of upper airway measuring by MRI.
Key secondary outcomes
none.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who scored 11 or more on the Epworth Sleepiness Scale or who fulfilled at least 2 criteria in the Berlin Questionnaire
2) Patients provided informed consent
Key exclusion criteria
1) Patients with a central sleep apnea score of 5 and higher
2) chronic heart failure
3) chronic respiratory failure (for example, those receiving oxygen therapy)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zen Isobe |
Organization
Isobe clinic
Division name
Department of respiratory medicine
Zip code
Address
926 Arai, Fukaya-shi, Saitama
TEL
048-575-1131
isobeit@sepia.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zen Isobe |
Organization
Isobe clinic
Division name
Department of respiratory medicine
Zip code
Address
926 Arai, Fukaya-shi, Saitama
TEL
048-575-1131
Homepage URL
isobeit@sepia.plala.or.jp
Sponsor or person
Institute
Isobe clinic
Institute
Department
Personal name
Funding Source
Organization
Isobe clinic
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
磯部クリニック（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Presented in part at the American Thoracic Society International Conference, San Diego, United States, May 20, 2014
Management information
Registered date
| 2015 | Year | 02 | Month | 22 | Day |
Last modified on
| 2015 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019255
