UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019045 |
|---|---|
| Receipt number | R000022022 |
| Scientific Title | Cross-over test for music and sound on sleep |
| Date of disclosure of the study information | 2015/09/16 |
| Last modified on | 2018/02/16 13:39:49 |
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Basic information
Public title
Cross-over test for music and sound on sleep
Acronym
Cross-over test for music and sound on sleep
Scientific Title
Cross-over test for music and sound on sleep
Scientific Title:Acronym
Cross-over test for music and sound on sleep
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 background noise only, with background noise and music (each condition for one night)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep latency
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
Pseudo-randomization
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
No sound (one night) - (wash out) - background noise (one night) - (wash out) - music(one night)
Interventions/Control_2
No sound (one night) -(wash out) - music (one night) - (wash out) - background noise(one night)
Interventions/Control_3
Background noise (one night) - (wash out) - no sound (one night) - (wash out) - music(one night)
Interventions/Control_4
Background noise(one night) - (wash out) - music (one night) - (wash out) - no sound(one night)
Interventions/Control_5
Music(one night) - (wash out) - background noise(one night) - (wash out) - no sound(one night)
Interventions/Control_6
Music(one night) - (wash out) - no sound (one night) - (wash out) - background noise(one night)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
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, MD, PhD |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
Address
Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPA
TEL
077-548-2291
kadotani@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kadotani, MD, PhD |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
Address
Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL
077-548-2291
Homepage URL
http://www.shiga-med.ac.jp/~hqpsy/toiawase.html
kadotani@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Psychiatry
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 精神科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
https://nx.ct-portal.com/exams/detail?id=26953
Publication of results
Partially published
Result
URL related to results and publications
http://www.c-linkage.co.jp/jssr40/docs/program/jssr40_poster_0703.pdf
Number of participants that the trial has enrolled
Results
No significant changes were found in sleep latency. Stage N3 latency was slightly decreased. This may be because participants were young and had short sleep latency. We plan to repeat this experiment with other participants and sounds.
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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | 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=R000022022
