UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028200 |
|---|---|
| Receipt number | 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 14:28:14 |
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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
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
kadotani@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Sleep and Behavioral Sciences,
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032281
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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