UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036986
Receipt number R000042136
Scientific Title The effect of improving oxygen saturation during sleep with an oral appliance and Nasal Breathing Stimulator(NBST).
Date of disclosure of the study information 2019/06/06
Last modified on 2020/12/07 09:30:56

* 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

The effect of improving oxygen saturation during sleep with an oral appliance and Nasal Breathing Stimulator(NBST).

Acronym

The effect of improving oxygen saturation during sleep with an oral appliance and Nasal Breathing Stimulator(NBST).

Scientific Title

The effect of improving oxygen saturation during sleep with an oral appliance and Nasal Breathing Stimulator(NBST).

Scientific Title:Acronym

The effect of improving oxygen saturation during sleep with an oral appliance and Nasal Breathing Stimulator(NBST).

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 treat OSA with MAD, and although the apnea-hypopnea index (Apnea Hypopnea Index: AHI) tends to improve, it is suspected that nasal congestion is not improved in the minimum oxygen saturation. We decided to examine the effects of combined therapy with MAD and nasal respiratory tract prostheses (NBST) in 45 patients. The judgment of effect is secondary analysis of 3% oxygen desaturation index, lowest arterial blood oxygen saturation, AHI, presence or absence of snoring noise, electroencephalogram, acupuncture electromyography, pulse, eye movement, Epworth Sleepiness Scale (ESS)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3% oxygen desaturation index, lowest arterial blood oxygen saturation, AHI

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Wearing OA and NBST

Interventions/Control_2

Wearing OA and Breathe right

Interventions/Control_3

Wearing OA and taking 10 deep breaths

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

Those who have been diagnosed with sleep apnea at the Institute Hospital of Nihon University School of Dentistry at Matsudo, or who have been diagnosed with sleep apnea at another medical institution and have visited our hospital or who have an otolaryngologic disorder

Key exclusion criteria

Those with central or mixed apnea, currently being treated for otolaryngologic diseases

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Suzuki

Organization

Nihon University School of Dentistry at Matsudo

Division name

Division of Oral Function and Rehabilitation, Department of Oral Health Science

Zip code

271-8587

Address

2-850-1 Sakaecho-nishi, Matsudo-shi, Chiba

TEL

0473609642

Email

maar17004@g.nihon-u.ac.jp


Public contact

Name of contact person

1st name Arisa
Middle name
Last name Sawa

Organization

Nihon University School of Dentistry at Matsudo

Division name

Division of Oral Function and Rehabilitation, Department of Oral Health Science

Zip code

271-8587

Address

2-850-1 Sakaecho-nishi, Matsudo-shi, Chiba

TEL

0473609642

Homepage URL


Email

maar17004@g.nihon-u.ac.jp


Sponsor or person

Institute

Nihon University School of Dentistry at Matsudo

Institute

Department

Personal name



Funding Source

Organization

Nihon University School of Dentistry at Matsudo

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University School of Dentistry at Matsudo

Address

2-850-1 Sakaecho-nishi, Matsudo-shi, Chiba

Tel

0473609642

Email

maar17004@g.nihon-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



Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

13

Results

RDI, SpO2min, ESS was significantly improved for NBS compared with the other conditions.

Results date posted

2020 Year 12 Month 07 Day

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

2019 Year 04 Month 20 Day

Date of IRB

2019 Year 04 Month 20 Day

Anticipated trial start date

2019 Year 04 Month 20 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry

2020 Year 12 Month 07 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 06 Month 06 Day

Last modified on

2020 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042136


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name