UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038232 |
|---|---|
| Receipt number | R000043409 |
| Scientific Title | The effectiveness of passive music therapy for sleep disorder of children with Autism Spectrum Disorder |
| Date of disclosure of the study information | 2019/10/08 |
| Last modified on | 2023/03/29 14:35:57 |
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Basic information
Public title
The effectiveness of passive music therapy for sleep disorder of children with Autism Spectrum Disorder
Acronym
The effectiveness of passive music therapy for sleep disorder of children with Autism Spectrum Disorder
Scientific Title
The effectiveness of passive music therapy for sleep disorder of children with Autism Spectrum Disorder
Scientific Title:Acronym
The effectiveness of passive music therapy for sleep disorder of children with Autism Spectrum Disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of music listening on sleep disorders and associated problem behavior in children with Autism Spectrum Disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the Japanese version of Children's Sleep Habit Questionnaire
Key secondary outcomes
Aberrant Behavior Checklist-Community
sleep scan SL-503(TANITA Co., Ltd., Tokyo, Japan)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
As a screening for a subject's sleep disorder, CSHQ-J was administered to his or her caregiver. Subjects with a CSHQ-J score of the cut-off value 42 or more were included in the intervention study. As an assessment of the subjects' behavior, ABC-J was administered to their caregivers. They listened to music at home for 40 minutes at bedtime every day for 4 weeks. After 4 weeks, CSHQ-J and ABC-J were administered to their caregivers again to compare the qualities of sleep before and after the intervention. In addition, their sleep qualities were objectively measured using a sleep meter every day for 4 weeks.
Interventions/Control_2
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
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Those who are 3 to 15 years old
(2)Those who have been admitted to the psychiatric outpatient department of Tokai University School of Medicine with a diagnosis of ASD
(3)Those who live at home
(4)Those who have received sufficient explanation for participation in this study and who have obtained written consent from their parents and their will
Key exclusion criteria
(1)Persons living in facilities
(2)Those who do not have an environment where they can listen to music using a speaker at bedtime
(3)Other persons who are deemed inappropriate by the supervisor or the research supervisor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokai University
Division name
Department of Psychiatry Tokai University School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa, JAPAN
TEL
0463-93-1121(2261)
key@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Yamasato |
Organization
Tokai University
Division name
Graduate School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa, JAPAN
TEL
0463-93-1121(2268)
Homepage URL
ami.yamasato@gmail.com
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine Grant
Kawai foundation for sound technology & music
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara City, Kanagawa, JAPAN
Tel
0463-93-1121(3446)
tokai-rinsho@ml.tokai-u.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
| 2019 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
53
Results
Forty-one patients were included in this analysis. Statistical analysis revealed significant improvements in CSHQ-J total score and in the following subscales: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Parasomnia, and Sleep-disordered Breathing. Regarding problem behaviors, significant improvements were found in the ABC-J total score and the Irritability, Lethargy, Hyperactivity, and Inappropriate Speech subscales.
Results date posted
| 2023 | Year | 03 | Month | 29 | Day |
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
| 2018 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 09 | 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
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043409
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
