UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056614 |
|---|---|
| Receipt number | R000064698 |
| Scientific Title | Effectiveness of a Novel One visit 3D printing titratable Interlocking Mandibular Advancement Device for Mild to Moderate Obstructive Sleep Apnea |
| Date of disclosure of the study information | 2025/01/02 |
| Last modified on | 2025/04/29 21:54:12 |
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Basic information
Public title
Effectiveness of a Novel One visit 3D printing titratable Interlocking Mandibular Advancement Device for Mild to Moderate Obstructive Sleep Apnea
Acronym
Digital MAD for OSA
Scientific Title
Effectiveness of a Novel One visit 3D printing titratable Interlocking Mandibular Advancement Device for Mild to Moderate Obstructive Sleep Apnea
Scientific Title:Acronym
Digital MAD for OSA
Region
| Asia(except Japan) |
Condition
Condition
Mild to moderate obstructive sleep apnea
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate respiratory event index (REI), Oxygen desaturation index (ODI), and snoring index (SI) improvement of the Newly designed digital interlocking MAD for mild to moderate OSA treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The newly designed digital interlocking MAD presents a promising alternative for managing mild to moderate OSA treatment.
Key secondary outcomes
The newly designed digital interlocking MAD offers acceptable effectiveness, reduced waiting times and lower costs.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Novel fully digital designed MAD
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
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 59 | years-old | > |
Gender
Male and Female
Key inclusion criteria
New patient diagnosed with mild to moderate OSA (AHI 5-30 per hour), At least 8 sound teeth per arch, Maximum protrusion at least 5 mm., Position-related OSA, No previous surgical treatment of OSA, Withdrawing from CPAP treatment for a minimum of 14 days
Key exclusion criteria
History of allergy to polymer-based resin/polymer, Unstable health condition e.g. pregnant, regular use of narcotics, sedative, psychiatric disorders, Other sleep related breathing disorders e.g. central sleep apnea, sleep-related hypoventilation, and sleep-related hypoxemia disorder, Acute or chronic painful TMD, Craniofacial anomaly, Heavy sleep bruxism, Refuse to follow a study protocol
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Asst. Prof. Dr. Supanigar |
| Middle name | |
| Last name | Ruangsri |
Organization
Faculty of Dentistry, Khon Kaen University, Thailand
Division name
Division of oral biology
Zip code
40002
Address
123, Moo 16 Thanon Mittraphap, Nai Mueang, Mueang Khon Kaen District, Khon Kaen, Thailand
TEL
66894224845
suprua@kku.ac.th
Public contact
Name of contact person
| 1st name | Asst. Prof. Dr. Supanigar |
| Middle name | |
| Last name | Ruangsri |
Organization
Faculty of Dentistry, Khon Kaen University, Thailand
Division name
Division of oral biology
Zip code
40002
Address
123, Moo 16 Thanon Mittraphap, Nai Mueang, Mueang Khon Kaen District, Khon Kaen, Thailand
TEL
66894224845
Homepage URL
suprua@kku.ac.th
Sponsor or person
Institute
National Science, Research and Innovation Fund (NSRF)
Institute
Department
Personal name
Funding Source
Organization
National Science, Research and Innovation Fund (NSRF)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Thai
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Ethics in Human Research, Khon Kaen University
Address
17th floor, Sor Vor 1 building, Faculty of Medicine, Khon Kaen University, 123 Mittraphap road, Nai Muang Subdistrict, Muang District, Khon Kaen, Thailand 40002
Tel
+6643-366621-3
eckku@kku.ac.th
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
Orofacial pain and dental sleep medicine clinic, Khon Kaen University, Thailand
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 02 | 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
25
Results
Significant improvements were observed in the respiratory event index (REI), supine REI, oxygen desaturation index, and percentage of snoring (p < 0.05).
Self-reported of quality of life, adherence and satisfaction were high, with only transient, mild side effects reported.
Results date posted
| 2025 | Year | 04 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064698
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/04/28 | Research plan.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/04/28 | Research case data specifications.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/04/28 | ~$Research case data.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/64698
