UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017060
Receipt number R000019783
Scientific Title The effectof coblation assisted uvulopalatppharyngoplasty on sleep disordered breathing
Date of disclosure of the study information 2015/04/06
Last modified on 2015/04/06 20:26:28

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Basic information

Public title

The effectof coblation assisted uvulopalatppharyngoplasty on sleep disordered breathing

Acronym

Coblation assisted UPPP for SDB

Scientific Title

The effectof coblation assisted uvulopalatppharyngoplasty on sleep disordered breathing

Scientific Title:Acronym

Coblation assisted UPPP for SDB

Region

Japan


Condition

Condition

sleep disordered breathing

Classification by specialty

Pneumology Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study effect of radiofrequency operation for sleep disordered breathing

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

excessive daytime sleepiness, snoring,apneahypopnea index, minimum oxygen desaturation, SpO2<90%, arousal index, health related QOL

Key secondary outcomes



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

coblation assisted uvulopalatopharyngoplasty

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

sleep disordered breathing

Key exclusion criteria

non-sleep disordered breathing

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken-ichi Hisamatsu

Organization

Nihon University Hospital

Division name

ENT Department

Zip code


Address

1-6Surugadai Kanda Chiyoda-ku Tokyo

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

Nihon University Hospital

Division name

ENT Department

Zip code


Address

1-6 Surugadai Kanda Chiyoda-ku Tokyo

TEL

03-3293-1711

Homepage URL


Email

kenhisam@jcom.home.ne.jp


Sponsor or person

Institute

Nihon University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of ENT, Nihon University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

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(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 06 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

Open public recruiting

Date of protocol fixation

2009 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 06 Day

Last follow-up date

2018 Year 01 Month 10 Day

Date of closure to data entry

2018 Year 03 Month 30 Day

Date trial data considered complete

2018 Year 05 Month 30 Day

Date analysis concluded

2018 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 04 Month 06 Day

Last modified on

2015 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019783


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name