UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039662 |
|---|---|
| Receipt number | R000045246 |
| Scientific Title | Examination of the effect of didjeridu health method on sleep apnea syndrome |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/12/04 18:51:00 |
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Basic information
Public title
Examination of the effect of didjeridu health method on sleep apnea syndrome
Acronym
Examination of the effect of didjeridu health method on sleep apnea syndrome
Scientific Title
Examination of the effect of didjeridu health method on sleep apnea syndrome
Scientific Title:Acronym
Examination of the effect of didjeridu health method on sleep apnea syndrome
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of didjeridu health method on sleep apnea syndrome symptoms and sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Items and symptoms of CPAP in CPAP use cases. Other than that, monitoring of airflow and oxygen saturation and snoring sound by simple inspection, and even symptoms. In addition, measurement of 8-OHdG (temporary urine) as oxidative stress.
Key secondary outcomes
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 |
Interventions/Control_1
Didgeridoo health method
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A case group of sleep apnea syndrome (obstructive sleep apnea syndrome) diagnosed by the Department of Otolaryngology, Kawasaki Medical School Hospital. A patient who goes to the hospital once a month. Some CPAP users are non-users, including both.Cases with written consent.
Key exclusion criteria
If you are not interested in the Didgeridoo Health Method, have difficulty making sounds, or cannot attend the lesson schedule, and for self-directed lessons, you will not be forced to work every day, but at all. However, if you do not take your own lessons, you will be asked to leave the entry in such cases.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takemi |
| Middle name | |
| Last name | Otsuki |
Organization
Kawasaki Medical School
Division name
Department of Hygiene
Zip code
7010192
Address
577 Mastushima, Kurashiki, Okayama, Japan
TEL
0864621111
otsuki.takemi.s05@gmail.com
Public contact
Name of contact person
| 1st name | Takemi |
| Middle name | |
| Last name | Otsuki |
Organization
Kawasaki Medical School
Division name
Department of Hygiene
Zip code
7010192
Address
577 Mastushima, Kurashiki, Okayama, Japan
TEL
0864621111
Homepage URL
otsuki.takemi.s05@gmail.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School / Affiliated Hospital Ethics Committee
Address
577 Mastushima, Kurashiki, Okayama, Japan
Tel
0864621111
kmsrec@med.kawasaki-m.ac.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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 04 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 04 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 04 | Day |
Other
Other related information
Canceled due to difficulty in recruiting cases due to COVID-19 and inability to secure a place for implementation. Waiting for the end of the COVID-19 wreck, we will make a new project.
Management information
Registered date
| 2020 | Year | 03 | Month | 02 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045246
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
