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 |
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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
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
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
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
