UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044877
Receipt number R000051256
Scientific Title Efficacy of Chin Strap for Obstructive Sleep Apnea
Date of disclosure of the study information 2021/07/16
Last modified on 2021/09/08 18:45:14

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Basic information

Public title

Efficacy of Chin Strap for Obstructive Sleep Apnea

Acronym

Efficacy of Chin Strap for OSA

Scientific Title

Efficacy of Chin Strap for Obstructive Sleep Apnea

Scientific Title:Acronym

Efficacy of Chin Strap for OSA

Region

Japan


Condition

Condition

Obstructive Sleep Apnea

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine whether a chin strap which is usually used in conjunction with CPAP is effective in treating OSA alone.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percent reduction in AHI while using the chin strap compared to the AHI at diagnosis

Key secondary outcomes

Arousal index
Oxygen desaturation index


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Use a chin strap to prevent the opening of the mouth.

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

Patients undergoing polysomnography for the diagnosis of OSA

Key exclusion criteria

Bilateral nasal obstruction
Allergy to the material (rubber) of the chinstrap

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Kasagi

Organization

Toranomon Hospital

Division name

Sleep Center

Zip code

105-8470

Address

Toranomon 2-2-2, Minato-ku, Tokyo

TEL

03-3588-1111

Email

s-kasagi@toranomon.gr.jp


Public contact

Name of contact person

1st name Yasuhiro
Middle name
Last name Tomita

Organization

Toranomon Hospital

Division name

Sleep Center

Zip code

105-8470

Address

Toranomon 2-2-2, Minato-ku, Tokyo

TEL

03-3588-1111

Homepage URL


Email

ytomita.tmy@gmail.com


Sponsor or person

Institute

Toranomon Hospital

Institute

Department

Personal name



Funding Source

Organization

Okinaka Memorial Institute for Medical Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethics committee of Toranomon Hospital

Address

Toranomon 2-2-2, Minato-ku, Tokyo

Tel

03-3588-1111

Email

chiken-jim@toranomon.gr.jp


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



Other administrative information

Date of disclosure of the study information

2021 Year 07 Month 16 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

Enrolling by invitation

Date of protocol fixation

2021 Year 07 Month 16 Day

Date of IRB

2021 Year 07 Month 21 Day

Anticipated trial start date

2021 Year 09 Month 08 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 16 Day

Last modified on

2021 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051256


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name