UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058472 |
|---|---|
| Receipt number | R000066805 |
| Scientific Title | Effects of 0.25 Hz binaural beats on sleep during nap in BB perceivers |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/15 15:04:34 |
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Basic information
Public title
Effects of 0.25 Hz binaural beats on sleep during nap in BB perceivers
Acronym
Effects of 0.25 Hz binaural beats on sleep during nap in BB perceivers
Scientific Title
Effects of 0.25 Hz binaural beats on sleep during nap in BB perceivers
Scientific Title:Acronym
Effects of 0.25 Hz binaural beats on sleep during nap in BB perceivers
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to test the hypothesis that presenting 0.25 Hz BB during a nap shortens the latency to slow-wave sleep in BB perceivers, compared to 0 Hz BB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Slow wave sleep latency
Key secondary outcomes
1)Sleep parameters other than slow wave sleep latency
2) Psychomotor vigilance test performance
3) Subjective sleepiness and mood
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A.Sham (no sound)
B.250-250Hz (0Hz pure tone)
C.250-250.25Hz (0.25Hz binaural beat)
Subjects go through a 90-minutes daytime nap for one condition in a day(total 3 days/ each subject).
The order of the conditions is (A, B, C).
Interventions/Control_2
The order of the conditions is (A, C, B).
Interventions/Control_3
The order of the conditions is (B, A, C).
Interventions/Control_4
The order of the conditions is (B, C, A).
Interventions/Control_5
The order of the conditions is (C, A, B).
Interventions/Control_6
The order of the conditions is (C, B, A ).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants will be included based on the following all criteria.
1)Not having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2)Being able to come to the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba without disrupting their normal daily rhythm
3)Living a regular life between 21:00-1:00 bedtime and 6:00-9:00 wake-up
4)Having no sleep disorder currently being treated
5)Having no hearing impairment in daily life
Key exclusion criteria
Participants will be excluded from the experiment based on the following criteria.
1)Irregular lifestyle (Regular: sleep time between 9:00 p.m. and 1:00 a.m., wake time between 6:00 a.m. and 9:00 a.m.)
2)BMI less than 18.5 or greater than 25
3)Worked night shifts (after 10:00 p.m.) 3 months prior to the experiment
4)Travel across time zones with time difference of 3 hours or more, 3 months prior to the experiment
5)regular consumes alcohol (40g (2 cans of beer) or more twice a week or more)
6)Smoker habit
7)Consumes more than 300mg (5 cups of 150mL) of coffee per day
8)MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type)
9)Pittsburgh Sleep Quality Index score greater than 5.5
10)Cannot perceive the frequency difference of the binaural beats and feel uncomfortable when listening to the auditory stimulation samples of this experiment
11)Claustrophobic
12)Pregnancy or its possibility
13)Breastfeeding
14)Having a disease that may change suddenly or its history
15)Having been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated
16)Deemed inappropriate by the principal investigator
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS), Tsukuba Institute for Advanced Research (TIAR)
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS), Tsukuba Institute for Advanced Re
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
Homepage URL
abe.takashi.gp@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Science and Technology Agency
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-3022
sien.ningenss@un.tsukuba.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 | 07 | Month | 15 | 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
| 2025 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | 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
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066805
