UMIN-CTR Clinical Trial

Public title

Impact of self oral myofunctional theraphy in the patients of obstructive sleep apnea syndrome

Acronym

Impact of self oral myofunctional theraphy in the patients of obstructive sleep apnea syndrome

Scientific Title

Impact of self oral myofunctional theraphy in the patients of obstructive sleep apnea syndrome

Scientific Title:Acronym

Impact of self oral myofunctional theraphy in the patients of obstructive sleep apnea syndrome

Region

Japan

Condition

obstructive sleep apnea syndrome

Classification by specialty

Medicine in general

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study is aimed to investigate the
efficacy of self oral myofunctional thraphy in obstructive sleep apnea syndrome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

changes of apnea hypopnea index(AHI) between before and 6 month after training

Key secondary outcomes

arousal index, minimum oxygen saturation,mean oxygen saturation, oxygen desaturation
index,sleep stages,snore index,
Epworth sleepiness scale,Pittsburgh sleep quality index,
frequency of nocturia,
red blood cell,hemoglobin,white blood cell,platelet,total protein, albumin, AST,ALT, LDH,
creatinine,LDL cholesterol,HDL cholesterol,triglyceride, HbA1C, blood suger,high sensitive C reactive protein,tongue pressure,circumference of abdomen and neck

Change of these factors above between before and 6 month after training

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Self oral myofunctional theraphy is performed three times a day for 6 months.
Patients are also educated to be conscious of nasal breathing and write down the daily
report.

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

1. out patients of Division of Comprehensive
Sleep Medicine in Tokyo Women's Medical University Hospital

2. Participant is diagnosed moderate or severe obstructive sleep apnea syndrome , who are treated using continuous positive airway pressure(CPAP) or oral appliance(OA) for more than 6 months.

3. Participant has no extreme body weight change from first diagnosed time.

Key exclusion criteria

1.mild obstructive sleep apnea syndrome
2.Participant has severe nasal obstruction.
3.obesity (BMI over 30)
4.Participant is recognized to be inadequate by principal investigator

Target sample size

100

Name of lead principal investigator

1st name	Nobuhisa
Middle name
Last name	Hagiwara,

Organization

Tokyo Women's Medical University

Division name

Department of Cardiology

Zip code

162-8666

Address

8-1 Kawada-cho Shinjuku-ku Tokyo, 162-8666 Japan

TEL

03-3353-8111

Email

mhagi@hij.twmu.ac.jp

Name of contact person

1st name	Mayumi
Middle name
Last name	Suzuki

Organization

Tokyo Women's Medical University

Division name

Department of Cardiology(Division of Comprehensive Sleep Medicine)

Zip code

162-8666

Address

8-1 Kawada-cho Shinjuku-ku Tokyo, 162-8666 Japan

TEL

03-3353-8111

Homepage URL

Email

suzuki.mayumi@twmu.ac.jp

Institute

Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Tokyo Women's Medical University
Department of Cardiology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Women's Medical University

Address

8-1 Kawada-cho Shinjuku-ku Tokyo, 162-8666 Japan

Tel

03-3353-8111

Email

rinri.bm@twmu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

30

Day

URL releasing protocol

10.1111/joor.13119

Publication of results

Published

URL related to results and publications

Efficacy of oral myofunctional therapy in middle aged to elderly patients with obstructive sleep apn

Number of participants that the trial has enrolled

41

Results

Patients were 69.3 years old. After 6 months of MFT, AHI decreased
significantly from 34.7 to 29.0/h (P = .03), while tongue pressure significantly increased
from 35.9 to 45.6 kPa (P < .01). Seven patients (22%), including 6 of the 12
patients with moderate OSA (50%), experienced successful CPAP discontinuation

Results date posted

2020

Year

12

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

For this trial, we recruited over 45 yearold patients with moderateto
severe OSA through the Division of Comprehensive Sleep
Medicine at the Tokyo Women's Medical University Hospital.
These patients had been treated with CPAP for more than 6 months.
Because the effects of CPAP persist for a few days after discontinuation,
11 we performed full polysomnography recordings
3 days after CPAP discontinuation. The PSG results obtained at
OSA diagnosis were retrospectively confirmed. AHI did not change
significantly with CPAP, and body weight did not vary significantly
at inclusion

Participant flow

We excluded patients with one or more of the following conditions:
body mass index were over 30 kg/m2, craniofacial malformation,
neuromuscular disease, previous stroke, heart failure or severe
obstructive nasal disease.
Among the 41 patients enrolled in this study, 1 was excluded
according to the exclusion criteria, 4 dropped out from the MFT
program during the 6 month training period, and 4 were excluded
due to low adherence

Adverse events

One patient had plastic surgery, because her hip joint problem worse during the training period, without the connection of this training.

Outcome measures

The primary outcome was AHI.
Secondary outcomes included ESS, average apnoea event duration,
AHI in the supine and lateral positions, AHI at the REM stage, minimal oxygen saturation, percentage of time spent in SpO2 90% with visually scored total sleep time, snore proportion
and tongue pressure.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2017

Year

02

Month

17

Day

Date of IRB

2017

Year

02

Month

17

Day

Anticipated trial start date

2017

Year

05

Month

30

Day

Last follow-up date

2019

Year

10

Month

04

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

30

Day

Last modified on

2020

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031575