UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055198 |
|---|---|
| Receipt number | R000063014 |
| Scientific Title | Development of sleep hygiene education as a treatment of oral lichen planus. |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2025/12/23 18:54:55 |
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Basic information
Public title
Development of sleep hygiene education as a treatment of oral lichen planus.
Acronym
Sleep quality and oral lichen planus.
Scientific Title
Development of sleep hygiene education as a treatment of oral lichen planus.
Scientific Title:Acronym
Sleep quality and oral lichen planus.
Region
| Japan |
Condition
Condition
Oral lichen planus
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Incorporating sleep hygiene education into treatment strategies for oral lichen planus.
Basic objectives2
Others
Basic objectives -Others
The verify whether sleep hygiene instructions can be used as a treatment for oral lichen planus.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of disease activity
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with oral lichen planus by pathological examination.
Key exclusion criteria
1. Those who have been diagnosed by pathological examination but have no subjective symptoms.
2. Those who have already been diagnosed with a sleep disorder.
3. Those who have the habit of drinking alcohol within 4 hours before falling asleep.
4. Patients who were unable to give consent.
5. Adults who lack the capacity to provide informed consent for participation in research involving self-administered sleep diaries.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | kazumichi |
| Middle name | |
| Last name | sato |
Organization
International University of Health and Welfare
Division name
Department of Oral Rehabilitation and Maxillofacial Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita City, Chiba
TEL
+81-476-35-5600
kazumichi312@gmail.com
Public contact
Name of contact person
| 1st name | kazumichi |
| Middle name | |
| Last name | sato |
Organization
International University of Health and Welfare
Division name
Department of Oral Rehabilitation and Maxillofacial Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita City, Chiba
TEL
+81-476-35-5600
Homepage URL
kazumichi312@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
852 Hatakeda, Narita City, Chiba
Tel
+81-476-35-5600
kazumichi312@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation period for each case, including the recording of symptoms and sleep diaries, is two months.
Management information
Registered date
| 2024 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063014
