UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057900 |
|---|---|
| Receipt number | R000066177 |
| Scientific Title | Investigation of changes in sleep after jaw resection. |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/05/19 07:44:34 |
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Basic information
Public title
Investigation of changes in sleep after jaw resection.
Acronym
Investigation of changes in sleep after jaw resection.
Scientific Title
Investigation of changes in sleep after jaw resection.
Scientific Title:Acronym
Investigation of changes in sleep after jaw resection.
Region
| Japan |
Condition
Condition
Patients with oral surgical disease who have undergone a jaw area resection are eligible. The mandible is defined as cases in which the jaw bone is divided, and the maxilla is defined as cases in which the maxillary molar tuberosity is included.
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Alterations in respiratory status following jaw resection may be problematic in oral surgical disease. The traction of the supratrochanteric musculature is weakened by the jaw osteotomy, resulting in tongue root subsidence, which may lead to respiratory distress and apnea.
In this study, we examine the changes in sleep after maxillectomy.
Basic objectives2
Others
Basic objectives -Others
Effects of Surgery on Sleep
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in AHI before and after surgery for patients with jaw area resection for oral surgical diseases.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are at least 18 years of age at the time of consent
2) Gender: Any gender
3) Patients who have been fully informed about their participation in this study, and who have given their consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
(1) Patients for whom a simple sleep apnea test is not possible
(2) Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sakamoto |
Organization
Kansai medical university medical center
Division name
Oral surgery
Zip code
5708507
Address
10-15Fumizono-cyo Moriguchi-shi Osaka-fu
TEL
0669939420
s.yukioutdoor@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sakamoto |
Organization
Kansai medical university medical center
Division name
Oral surgery
Zip code
5708507
Address
10-15Fumizono-cyo Moriguchi-shi Osaka-fu
TEL
09086076285
Homepage URL
s.yukioutdoor@gmail.com
Sponsor or person
Institute
Kansai medical university
Institute
Department
Personal name
Yuki Sakamoto
Funding Source
Organization
Kansai medical 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
Kansai Medical University Medical Center
Address
10-15 Fumizono-cho
Tel
09086076285
s.yukioutdoor@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066177
