UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018643 |
|---|---|
| Receipt number | R000021577 |
| Scientific Title | Evaluation of mandibular advancement device with high compliance rate for obstructive sleep apnea patient |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2024/02/16 09:59:25 |
* 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
Evaluation of mandibular advancement device with high compliance rate for obstructive sleep apnea patient
Acronym
Evaluation of mandibular advancement device with high compliance rate for obstructive sleep apnea patient
Scientific Title
Evaluation of mandibular advancement device with high compliance rate for obstructive sleep apnea patient
Scientific Title:Acronym
Evaluation of mandibular advancement device with high compliance rate for obstructive sleep apnea patient
Region
| Japan |
Condition
Condition
obstructive sleep apnea syndrome
Classification by specialty
| Pneumology | Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the differences of usability and quality of sleep between soft-type device and hard -type device for OSAS patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usability of AMP device after using AMP devices for 2 weeks
Key secondary outcomes
Quality of sleep after using AMP diverse for 2 weeks
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
teat with soft-type AMP device then treat with hard-type AMP device
Interventions/Control_2
teat with hard-type AMP device then treat with soft-type AMP device
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. Obstructive slepp apnea syndrome patient diagnosed by full polysomunography study
2. OSAS patients who need to treat of AMP device
3. >20 years of age
Key exclusion criteria
1. Patients who has underwent other treatment for OSAS
2. Patients with central sleep apnea dominance (CAI >5/hr)
3. Patients with other sleep disorders
4. Patients with mental disorders
5. Patients with craniofacial disorders
6. Patients with multiple teeth loss
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Makihara |
Organization
Kyushu Dental University
Division name
Division of Occlusion & Maxillofacial Reconstruction
Zip code
803-8580
Address
2-6-1 Manazuru, Kokura- Kita-Ku, Kitakyushu, Japan
TEL
093-582-1131
maki-eri@yu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Makihara |
Organization
Kyushu Dental University
Division name
Division of Occlusion & Maxillofacial Reconstruction
Zip code
8038580
Address
2-6-1 Manazuru, Kokura- Kita-Ku, Kitakyushu, Japan
TEL
093-582-1131
Homepage URL
maki-eri@kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Dental University
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
Kyushu Dental University
Address
2-6-1 Manazuru Kokura-Kita-Ku,Kitakyushu
Tel
093-582-1131
maki-eri@kyu-dent.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
| 2015 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
no URL
Publication of results
Partially published
Result
URL related to results and publications
no URL
Number of participants that the trial has enrolled
7
Results
Discomfort caused by the oral appliance was greater for the soft type appliance than for the hard type appliance in the following patient assessed variables: Dry mouth; Ill fitting appliance and Difficulty sleeping.
Only two patient exhibited a complete match between results of sleep data and the type of oral appliance that the patient wanted to continue using.
Results date posted
| 2022 | Year | 02 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Discomfort caused by the oral appliance was greater for the soft type appliance than for the hard type appliance in the following patient-assessed variables: Dry mouth; Ill fitting appliance and Difficulty sleeping. Conversely, discomfort was greater for the hard type appliance in the following variables: Excessive salivation, Discomfort,Difficulty closing lips, Difficulty wearing appliance, Occlusal change ,Increase in bruxism, Discomfort in the TMJ area, TMJ noise, Pain in the oral tissue region, Pain in the teeth, Difficulty sleeping.
Only two patients exhibited a complete match between results of sleep data and the type of oral appliance that the patient wanted to continue using.
Participant flow
1. Determination of therapeutic jaw position
2. The agreement acquisition
3. OA wearing 1 for the experiment
4. Questionnaire 1 about a sleep change measurement at the time of the OA wearing and the usability
5. OA wearing 2 for the experiment
6. Questionnaire 2 about a sleep change measurement at the time of the OA wearing and the usability
7. Data analysis
Adverse events
No Important Notice
Outcome measures
(1) patient responses regarding sensation
The subject answered the questionnaire about degree of the discomfort for each OAs
(2)sleeping conditions
Sleep conditions with wearing each OAs were recorded by the Sleep Scope for three nights.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021577
