UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044417 |
|---|---|
| Receipt number | R000050744 |
| Scientific Title | Effects of auditory stimulation during NREM sleep on mood |
| Date of disclosure of the study information | 2021/06/04 |
| Last modified on | 2021/06/03 19:07:55 |
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Basic information
Public title
Effects of auditory stimulation during NREM sleep on mood
Acronym
Effects of auditory stimulation during NREM sleep on mood
Scientific Title
Effects of auditory stimulation during NREM sleep on mood
Scientific Title:Acronym
Effects of auditory stimulation during NREM sleep on mood
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal is to see if closed-loop auditory stimuli could be used to enhance the slow oscillation and reduce anxiety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective anxiety using the questionnaire(State-Trait) Anxiety Inventory - subscale scores of state anxiety)
Key secondary outcomes
1)The change of power in the slow wave activity frequency with and without auditory stimuli
2)Amplitude of slow wave
3)Sleep variables obtained by polysomnography
4)Heart rate variability
5)Electroencephalogram (EEG)
6)Electrooculogram (EOG)
7)Electromyogram (EMG)
8)Respiration
9)The changes of skin conductance change
10)Psychomotor vigilance test performance
11)Subjective sleepiness by a questionnaire (Karolinska Sleepiness Scale)
12)Subjective sleep evaluation after waking up (Oguri-Shirakawa-Azumi Sleep inventory)
13)Subjective mood and affect (Profile of Mood State 2, Positive and Negative Affect Schedule)
14)Characteristic waves of sleep EEG
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Two nights' sleep in order of auditory condition and no auditory condition.
Interventions/Control_2
Two nights' sleep in order of no auditory condition and auditory condition.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will be included in the following all criteria.
1) Having no difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2) No claustrophobia and 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) High scores of State-Trait Anxiety Inventory - subscale scores of trait anxiety (45-80 point)
Key exclusion criteria
Participants will be excluded from the experiment based on the following criteria.
1)BMI less than 18.5 or greater than 25
2)Worked night shifts (after 10pm) 3 months prior to the experiment
3) Travel across time zones with time
Difference of 3 hours or more, 3 months prior to the experiment
4) Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more)
5)Smoker
6) Consumes more than 400 mg (Based on the maximum caffeine intake of healthy adults without adverse effects [European Food Safety Authority, Health Canada],5 cups of 150mL) of coffee every day
7) MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type)
8) Those who cannot perceive the auditory stimulation and feel uncomfortable when listening to samples of this experiment.
9) Pregnancy or its possibility
10) Lactation
11) Those who have a disease that may change suddenly or its history
12) Those who have been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated
13)Candidates of Participants who follow all inclusion criteria, but exclusion criteria 1) -12) will be reported to psychiatrist. Psychiatrist interviews as needed to determine the unsuitable person as a subject.
14) Subjects judged by the principal investigator to be inappropriate
Target sample size
16
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
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
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
Japan Society For The Promotion Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee, University of Tsukuba Hospital
Address
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
| 2021 | Year | 06 | Month | 04 | 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
| 2021 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2021 | Year | 06 | Month | 03 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050744
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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