UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039936
Receipt number R000045526
Scientific Title Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea
Date of disclosure of the study information 2020/03/27
Last modified on 2023/11/21 16:22:43

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Basic information

Public title

Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea

Acronym

Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea

Scientific Title

Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea

Scientific Title:Acronym

Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea

Region

Japan


Condition

Condition

obstructive sleep apnea

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to improve our understanding of the physical characteristics of patients with OSA by measuring muscle stiffness in the submental region in both patients with OSA and non-apneic persons.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement of submental muscle stiffness at the habitual occlusal position (HOP), the maximum mandibular protrusive position (MPP) and the tongue protrusive position (TPP) during stopping breathing.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

habitual occlusion: HO

Interventions/Control_2

tongue protrusive position: TPP

Interventions/Control_3

maximum mandibular protrusive position: MPP

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

patients with OSA without other sleep disorders based on overnight PSG test at the medical institutions
healthy participants recruited from dentists or medical staffs of Kyushu Dental University.

Key exclusion criteria

signs and symptoms related to temporomandibular disorders, a history of psychological problems, or occlusion dysfunction
healthy participants with ODI>5

Target sample size

14


Research contact person

Name of lead principal investigator

1st name Eri
Middle name
Last name Makihara

Organization

Kyushu Dental University

Division name

Division of Occlusion & Maxillofacial Reconstruction

Zip code

803-8580

Address

2-6-1 Manazuru, Kokurakita-ku, Kitakyushu

TEL

093-582-1131

Email

maki-eri@kyu-dent.ac.jp


Public contact

Name of contact person

1st name Eri
Middle name
Last name Makihara

Organization

Kyushu Dental University

Division name

Division of Occlusion & Maxillofacial Reconstruction

Zip code

803-8580

Address

2-6-1 Manazuru, Kokurakita-ku, Kitakyushu

TEL

093-582-1131

Homepage URL


Email

maki-eri@kyu-dent.ac.jp


Sponsor or person

Institute

Kyushu Dental University

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu Dental University

Address

2-6-1 Manazuru, Kokurakita-ku, Kitakyushu

Tel

093-582-1131

Email

maki-eri@kyu-dent.ac.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

2020 Year 03 Month 27 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

Completed

Date of protocol fixation

2018 Year 12 Month 07 Day

Date of IRB

2018 Year 12 Month 17 Day

Anticipated trial start date

2020 Year 03 Month 27 Day

Last follow-up date

2024 Year 03 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

2020 Year 03 Month 25 Day

Last modified on

2023 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045526


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name