UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039316
Receipt number R000044844
Scientific Title Evaluation of hyoid muscles during wakefulness forced snoring in non-obese young adults with obstructive sleep apnea using dynamic magnetic resonance imaging
Date of disclosure of the study information 2020/02/01
Last modified on 2024/02/02 12:10:17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Neck in obstructive sleep apnea by MRI

Acronym

Neck MRI in obstructive sleep apnea

Scientific Title

Evaluation of hyoid muscles during wakefulness forced snoring in non-obese young adults with obstructive sleep apnea using dynamic magnetic resonance imaging

Scientific Title:Acronym

Evaluation of hyoid muscles in obstructive sleep apnea using MRI

Region

Japan


Condition

Condition

visitors of sleep clinic

Classification by specialty

Medicine in general Psychiatry Oto-rhino-laryngology
Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Correlation the stenosis rate of the pharynx and larynx between during wakefulness forced snoring between the laryngeal endoscopy and dynamic MRI

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation the stenosis rate of the pharynx and larynx between during wakefulness forced snoring between the laryngeal endoscopy and dynamic MRI

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

Diagnosis

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention of dynamic MRI examination of the pharynx and larynx during wakefulness forced snoring

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Subjects who had required polysomnography at sleep clinic in Kurume University School Hospital
2. 20 years old and over
3. Obtained written informed consents

Key exclusion criteria

1. Obese with body mass index > 25kg/m2
2. Abnormalities of face skeleton
3. Swelling of tonsils and/or adenoid grands
4. Rhinosinusitis
5. Mental, psychotropic and anxiolytic disorders, and users of mental, psychotropic and anxiolytic and insomnia medicines
6. Dementia, and central and peripheral nerve system disorders, and muscles disorders
7. Heart failure
8. Pregnancy and nursing
9. Patients with other severe diseases and who judged inappropriate by physicians
10. Subjects who should not be required MRI such as claustrophobia, implanted metal by surgery and tattoo
11. Subjects who cannot perform wakefulness forced snoring

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Tomotaka
Middle name
Last name Kawayama

Organization

Kurume University

Division name

Dapartment of Medicine

Zip code

8300011

Address

67 Asahi-machi, Kurume 830-0011

TEL

0942-31-7560

Email

kawayama_tomotaka@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name Tomotaka
Middle name
Last name Kawayama

Organization

Kurume University

Division name

Dapartment of Medicine

Zip code

8300011

Address

67 Asahi-machi, Kurume 830-0011

TEL

0942-31-7560

Homepage URL


Email

kawayama_tomotaka@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University

Institute

Department

Personal name



Funding Source

Organization

KAKEN

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics board of Medicine, Kurume University

Address

67 Asahi-machi, Kurume 830-0011

Tel

0942-65-3749

Email

i_rinri@kurume-u.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

久留米大学病院


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 01 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

2020 Year 01 Month 15 Day

Date of IRB

2020 Year 01 Month 28 Day

Anticipated trial start date

2020 Year 01 Month 28 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2024 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 30 Day

Last modified on

2024 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044844


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name