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

Email

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

Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name