UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014723 |
|---|---|
| Receipt number | R000017028 |
| Scientific Title | Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome: multicenter, open label, prospective randomized non-inferiority crossover trial |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2018/08/03 13:43:55 |
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Basic information
Public title
Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome: multicenter, open label, prospective randomized non-inferiority crossover trial
Acronym
Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome
Scientific Title
Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome: multicenter, open label, prospective randomized non-inferiority crossover trial
Scientific Title:Acronym
Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Cardiology | Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of MAD (Somnodent®) and the continuous positive airway pressure (CPAP) on the cardiovascular system by comparing the changes in endothelial function measured by flow-mediated dilatation (FMD) among patients with moderate sleep apnea syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of change in FMD at the end of each course of therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
treat with CPAP then treat with MAD
Interventions/Control_2
treat with MAD then treat with CPAP
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: >20 years of age
2: 20<AHI<=40 by full polysomnography study
3: With two criteria for OSAS symptoms
4: With postural dependency defined as (AHI of supine position > 2 times AHI during sleeping position other than supine)
Key exclusion criteria
1. History of treatment of OSAS
2. Patients who needs to treat immediately
3. With central sleep apnea dominance (CAHI>5)
4. With insomnia or hypersomnia not relate to OSAS
5. Using sedatives,
6. With pulmonary (asthma, COPD etc.) or mental disease which needs to treat
7. Unable to fit MAD
8. With coronary heart disease and cerebrovascular disease
9. On hemodialysis
10. Patients who are judged unsuitable to participate in the study by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Ando |
Organization
Kyushu university hospital
Division name
Sleep Apnea Center
Zip code
Address
3-1-1 Maidashi Higashiku Fukuoka Japan
TEL
093-642-5987
shinando@sleep.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Ando |
Organization
Kyushu university hospital
Division name
Sleep Apnea Center
Zip code
Address
3-1-1 Maidashi Higashiku Fukuoka Japan
TEL
093-642-5987
Homepage URL
shinando@sleep.med.kyushu-u.ac.jp
Sponsor or person
Institute
Sleep apnea center,Kyushu university hospital
Institute
Department
Personal name
Funding Source
Organization
sleep apnea center,Kyushu university hospital
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
Address
Tel
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
| 2014 | Year | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 31 | Day |
Last modified on
| 2018 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017028
