UMIN-CTR Clinical Trial

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
Institute	Nihon University School of Dentistry at Matsudo
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042136