UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059640 |
|---|---|
| Receipt number | R000068166 |
| Scientific Title | Effect of Mouth-Taping and Simple Oral Motor Training on Sleep Quality and Salivary Secretion in Young Women: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/11/05 12:19:38 |
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Basic information
Public title
Effect of Mouth-Taping at Bedtime on Sleep Satisfaction in Young Women
Acronym
Mouth-Taping Sleep Improvement Study
Scientific Title
Effect of Mouth-Taping and Simple Oral Motor Training on Sleep Quality and Salivary Secretion in Young Women: A Randomized Controlled Trial
Scientific Title:Acronym
Young Women Mouth-Taping RCT
Region
| Japan |
Condition
Condition
Mild sleep disturbance
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of mouth taping at bedtime on sleep quality in young women.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine the effects of mouth taping at bedtime and simple oral motor training on sleep quality and salivary secretion in young women. The study aims to clarify whether these non-medical and easy-to-perform oral care interventions can contribute to improving sleep and preventing oral dryness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep satisfaction (self-rated on a 0-10 numerical scale)
Key secondary outcomes
Salivary secretion volume, oral dryness, nasal obstruction, daytime fatigue, tongue position, lip dryness, dry mouth upon awakening
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the intervention group will apply surgical mouth tape at bedtime for 30 days and perform 30 repetitions per day of a simple oral muscle exercise (A-I-U-BE training).
Interventions/Control_2
The control group will maintain their usual lifestyle.
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
| 19 | years-old | >= |
Gender
Female
Key inclusion criteria
Female students without severe sleep-related disorders
Able to complete questionnaires in Japanese
Key exclusion criteria
Individuals with severe nasal obstruction requiring mouth breathing
History of sleep apnea syndrome
Serious oral diseases
Those who do not provide informed consent
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | kiyomi |
| Middle name | |
| Last name | kaneko |
Organization
Ota College of Medical Technology
Division name
Department of Dental Hygiene
Zip code
3730812
Address
1373 Higashi-Nagaoka, Ota City, Gunma
TEL
0276252414
k-kaneko@ojs.ac.jp
Public contact
Name of contact person
| 1st name | kiyomi |
| Middle name | |
| Last name | kaneko |
Organization
Ota College of Medical Technology
Division name
Department of Dental Hygiene
Zip code
3730812
Address
1373 Higashi-Nagaoka, Ota City, Gunma
TEL
0276252414
Homepage URL
k-kaneko@ojs.ac.jp
Sponsor or person
Institute
Ota College of Medical Technology
Institute
Department
Personal name
Funding Source
Organization
no
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
Ota College of Medical Technology-Medical Ethics Review Committee
Address
1373 Higashi-Nagaoka, Ota City, Gunma
Tel
0276252414
k-kankeo@ojs.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
| 2025 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
This study was a preliminary investigation and was not registered in the UMIN-CTR.
Publication of results
Unpublished
Result
URL related to results and publications
Publication pending
Number of participants that the trial has enrolled
45
Results
Sleep satisfaction in the intervention and control groups was 6.4SD0.5 and 5.8SD0.4, respectively, at baseline, with no significant difference between the groups. At the end of the study, the intervention group showed a score of 7.1SD0.4, while the control group remained at 5.8SD0.4. A significant increase was observed in the intervention group, whereas no significant change was noted in the control group.
Results date posted
| 2025 | Year | 11 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants: First-year female students at Ota Medical College
Total number: 45
Intervention group: 23
Control group: 22
Age: Intervention group 18.7SD0.5 years, Control group 18.7SD0.6 years
Health status: No history of severe sleep-related disorders
Exclusion criteria: Severe nasal obstruction limiting nasal breathing, history of sleep apnea syndrome, severe oral diseases
Others: All participants were able to complete questionnaires in Japanese
Participant flow
Enrollment & Screening
Participants: 45 first-year female students at Ota Medical College
Inclusion criteria: No history of severe sleep-related disorders, able to complete questionnaires in Japanese
Exclusion criteria: Severe nasal obstruction limiting nasal breathing, history of sleep apnea syndrome, severe oral diseases, or lack of consent
Randomization
Intervention group (mouth taping + simple oral exercises): 23
Control group (no intervention): 22
Intervention period (30 days)
Intervention group: Nightly mouth taping + 30 repetitions of "Ai-U-Be" exercises per day
Control group: Usual daily life
Assessment & Analysis
Questionnaires and salivary flow measurements at baseline and after 30 days
Primary outcome: Sleep satisfaction
Secondary outcomes: Salivary flow, tongue position, mouth opening during class, lip dryness, chin muscle tension, sleep behavior, dry mouth upon waking, nasal obstruction, daily fatigue
All participants in both groups were included in the analysis; no dropouts
Adverse events
The mouth taping and simple oral exercises used in this study are existing methods and commonly used products with confirmed high safety.
No serious adverse events were reported during the study period.
No minor discomfort or skin irritation related to mouth taping was reported.
Participants with severe nasal obstruction did not undergo mouth taping, ensuring safety.
Outcome measures
Salivary flow over 2 minutes (ml)
Tongue tip position during mouth opening
Mouth opening status during class
Water intake during meals
Lip dryness
Chin (mentalis) muscle tension at mouth closure
Sleep behavior
Dry mouth upon waking
Sleep satisfaction
Nasal obstruction / difficulty in nasal breathing
Daily fatigue
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | 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 | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068166
