UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019665 |
|---|---|
| Receipt number | R000022452 |
| Scientific Title | Effects of nasal congestion on sleep apnea |
| Date of disclosure of the study information | 2015/11/07 |
| Last modified on | 2015/11/26 18:36:19 |
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Basic information
Public title
Effects of nasal congestion on sleep apnea
Acronym
Effects of nasal congestion on sleep apnea
Scientific Title
Effects of nasal congestion on sleep apnea
Scientific Title:Acronym
Effects of nasal congestion on sleep apnea
Region
| Japan |
Condition
Condition
Sleep-disordered breathing
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantification of the impact of nasal obstruction on sleep-disordered breathing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy in the reduction of 3%ODI
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients undergoing endoscopic nasal surgery
Key exclusion criteria
Participation judged by physician to be inadvisable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kojiro Ishioka |
Organization
Niigata University, Faculty of Medicine
Division name
Otolaryngology, Head and Neck surgery
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL
+81-25-227-2306
kojiro1@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kojiro Ishioka |
Organization
Niigata University, Faculty of Medicine
Division name
Otolaryngology, Head and Neck surgery
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL
+81-25-227-2306
Homepage URL
kojiro1@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Self-funding
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 07 | 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
Suspended
Date of protocol fixation
| 2012 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: A cohort study on consecutive patients.
Patients recruitment: All patients who underwent surgery for sinonasal lesions that meet the selection criteria at our facility from July 2013-.
Observations: 3%ODI, rhinomanometry
Management information
Registered date
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022452
