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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044417
Receipt No. 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

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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
Email 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
Email abe.takashi.gp@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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