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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028200
Receipt No. R000032281
Scientific Title Cross-over test for music and sound on sleep 2
Date of disclosure of the study information 2017/07/12
Last modified on 2018/02/16

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Basic information
Public title Cross-over test for music and sound on sleep 2
Acronym Cross-over test for music and sound on sleep 2
Scientific Title Cross-over test for music and sound on sleep 2
Scientific Title:Acronym Cross-over test for music and sound on sleep 2
Region
Japan

Condition
Condition insomnia
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze effects of sound and music on sleep, crossover test with in-laboratory polysomnography will be carried on under three conditions: no sound, with noise (white noise), or with music (each condition for one night)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Sleep latency (N1,N2,N3)
Key secondary outcomes Time under N3 sleep, delta power, number of wake, time of Wake After Sleep Onset, HF and HF from ECG, concentration of amylase and steroid from saliva

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 No sound - (wash out) - noise - (wash out) - music
Interventions/Control_2 No sound - (wash out) - music - (wash out) - noise
Interventions/Control_3 No sound - (wash out) - music - (wash out) - noise
Interventions/Control_4 noise - (wash out) - music - (wash out) - no sound
Interventions/Control_5 Music - (wash out) - noise - (wash out) - no sound
Interventions/Control_6 Music - (wash out) - no sound - (wash out) - noise
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteers over 20 years old
Key exclusion criteria Diagnosed sleep disorders, hearing loss, employees or family of employees of YAMAHA
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kadotani
Organization Shiga University of Medical Science
Division name Department of Sleep and Behavioral Sciences
Zip code
Address Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL 077-548-3632
Email kadotani@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kadotani
Organization Shiga University of Medical Science
Division name Department of Sleep and Behavioral Sciences
Zip code
Address Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL 077-548-3632
Homepage URL http://www.shiga-med.ac.jp/~hqsuimin/170517_yamaha.pdf
Email kadotani@belle.shiga-med.ac.jp

Sponsor
Institute Department of Sleep and Behavioral Sciences,
Shiga University of Medical Science
Institute
Department

Funding Source
Organization YAMAHA
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor YAMAHA
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 滋賀医科大学(滋賀県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 12 Day

Related information
URL releasing protocol https://nx.ct-portal.com/exams/detail?id=35009
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 Completed
Date of protocol fixation
2017 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 12 Day
Last modified on
2018 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032281

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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