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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011997
Receipt No. 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

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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
Email 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
Email kenhisam@jcom.home.ne.jp

Sponsor
Institute Nihon University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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