UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048122 |
|---|---|
| Receipt number | R000054828 |
| Scientific Title | Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep |
| Date of disclosure of the study information | 2022/06/25 |
| Last modified on | 2024/06/07 12:25:52 |
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Basic information
Public title
Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep
Acronym
Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep
Scientific Title
Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep
Scientific Title:Acronym
Effects of auditory stimulation on night sleep in individuals with difficulty falling asleep
Region
| Japan |
Condition
Condition
Insomnia symptoms
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the slow wave sleep latency effected by continuous auditory stimulation (0.25Hz binaural beat) during night sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Slow wave sleep latency
Key secondary outcomes
1) Sleep variables other than slow wave sleep latency obtained by polysomnography
2) Heart rate variability during sleep
3) Electroencephalogram during sleep
4) Psychomotor vigilance test performance
5) Subjective sleepiness and mood
6) Subjective reports on night sleep
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
A.Sham (no sound)
B.250-250.25Hz (0.25Hz binaural beat)
Subjects go through a night sleep for one condition in a day (total 2 days/ each subject).
The order of the conditions is (A,B).
Interventions/Control_2
The order of the conditions is (B, A).
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will be included on the following all criteria.
1) Not having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2) Being able to stay in the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba.
3) Having no sleep disorder currently being treated
4) Having no hearing impairment in daily life
5) Subjectively reporting difficulty falling asleep for more than 30 minutes at least 3 times per week during the last 3 months
Key exclusion criteria
Participants will be excluded from the experiment based on the following criteria.
1) Irregular lifestyle (Regular: sleep time between 9pm and 1am, wake time between 6am and 9am)
2) BMI less than 18.5 or greater than 25
3) Worked night shifts (after 10pm) 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) Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more)
6) Smoker
7) Consumes more than 300mg (5 cups of 150mL) of coffee every day
8) MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type)
9) Pittsburgh Sleep Quality Index score of less than 5 or Insomnia Severity Index score of less than 7.
10) Those who 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) Lactation
14) Those who have a disease that may change suddenly or its history
15) Those who have been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated
16) Suicidal ideation (item 9 on the Beck Depression Scale of greater than 2)
17) Subjects judged by the investigator to be inappropriate
Target sample size
18
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)
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, 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)
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, 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
Kyocera Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyocera Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-5876, Japan
Tel
029-853-3914
jisedai@md.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
| 2022 | Year | 06 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054828
