UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011171 |
|---|---|
| Receipt number | R000013018 |
| Scientific Title | Pilot Study for ORAl myofunctional CLinical Evidence: elderly |
| Date of disclosure of the study information | 2013/07/11 |
| Last modified on | 2019/09/29 14:35:02 |
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Basic information
Public title
Pilot Study for ORAl myofunctional CLinical Evidence: elderly
Acronym
ORACLE Pilot, TSUBAKI
Scientific Title
Pilot Study for ORAl myofunctional CLinical Evidence: elderly
Scientific Title:Acronym
ORACLE Pilot, TSUBAKI
Region
| Japan |
Condition
Condition
Elders who need care
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform pilot study for creating evidence of oral myofunctional training in elders who need care in sleeping condition. To evaluate indicators from viewpoints of improving activities of daily living (ADL) and quality of life (QOL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleeping stage, apnea and hypopnea assessed by polysomnography
Key secondary outcomes
Blood pressure, pulse, frequency of stool, height, weight, grip strength, functional independence measurement (FIM), Mini-Mental State (MMSE), GDS, depressive state (PHQ9), oral examination, amount of saliva, cardiovascular and other vascular events, death by all cause
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Oral myofunctional training program
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Person who lives or visits regularly in Social Welfare Corporation Tsubakigaoka, an Intensive Care Home for the Elderly.
2) Person whoare age from 65.
3) Person who is qualified as a Person Requiring Lon-Term Care.
Key exclusion criteria
1) Person who is mechanically-entilated.
2) Person who has serious conditions in the oral cavity
3) who is unable to obtain agreement.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
81-92-642-5360
tomomi_i@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University
Division name
Department of Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Fukuoka
TEL
095-801-8023
Homepage URL
info@ffc-p.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Network Fukuoka
Address
3-1-1, Maidashi, Higashiku, Fukuoka
Tel
092-643-7171
mail@crnfukuoka.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
社会福祉法人椿ヶ丘特別養護老人ホーム椿ヶ丘荘
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 11 | 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 | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 17 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 17 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013018
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
