UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011997 |
|---|---|
| Receipt number | R000013857 |
| Scientific Title | Effect of compound nasal surgery on sleep disordered breathing |
| Date of disclosure of the study information | 2013/10/09 |
| Last modified on | 2014/10/17 18:50:17 |
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Basic information
Public title
Effect of compound nasal surgery on sleep disordered breathing
Acronym
Effective nasal surgery on sleep disordered breathing
Scientific Title
Effect of compound nasal surgery on sleep disordered breathing
Scientific Title:Acronym
Effective nasal surgery on sleep disordered breathing
Region
| Japan |
Condition
Condition
Sleep disordered breathing
Classification by specialty
| Pneumology | Oto-rhino-laryngology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of compound nasal surgery on sleep disordered breathing
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
PSG events(AI, AHI, ODI, SpO2<90%, arousal index), daytime sleepiness,
QOL and snoring
Key secondary outcomes
postoperatively 3 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Compound nasal surgery
Sleep disordered breathing: postoperatively 3 months
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients suffered from SDB with nasal diseases. SDB contains OSAS, snoring and excessive daytime sleepiness
Key exclusion criteria
SDB patients without nasal diseases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Hisamatsu |
Organization
Nihon University Hospital
Division name
Department of Ear Nose Throart and Head & Neck Surgery
Zip code
Address
1-16 Surugadai, Kanda, Chiyoda-ku
TEL
03-3293-1711
kenhisam@jcom.home.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Hisamatsu |
Organization
Tsuchiura Snoring & SDB Center
Division name
Department of Ear Nose Throart
Zip code
Address
2-4-21 Chuo, Tsuchiura City,
TEL
03-3293-1711
Homepage URL
kenhisam@jcom.home.ne.jp
Sponsor or person
Institute
Nihon University Hospital
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
Tsuchiura Snoring & SDB Center
Name of secondary funder(s)
None
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
日本大学病院/Nihon University Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 09 | 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
ameliolation of AI, AHI, arousal index, ODI, ESS, snoring, QOL
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
| 2011 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
nasal resistance, Modified Mallampatti Classification, BMI
Management information
Registered date
| 2013 | Year | 10 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013857
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
