UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050529 |
|---|---|
| Receipt number | R000044539 |
| Scientific Title | Efficacy of Yoga therapy on the patients with imsomnia: a randomized cross-over pilot study. |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2023/09/12 11:37:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of Yoga therapy on the patients with imsomnia: a randomized cross-over pilot study.
Acronym
Study on the effects of yoga therapy on insomnia
Scientific Title
Efficacy of Yoga therapy on the patients with imsomnia: a randomized cross-over pilot study.
Scientific Title:Acronym
Efficacy of Yoga therapy on the patients with imsomnia: a randomized cross-over pilot study.
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the conditions to clarify the effects of yoga on insomnia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
St. Mary's Hospital Sleep Questionnaire
Key secondary outcomes
1.The change of sleep
2.The score of STAI
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
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
yoga therapy
Interventions/Control_2
Waiting list
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subject who are suffering from insomnia
with more than 6 point of AIS.
Key exclusion criteria
1.Subject who are suffering from mental disorder other than insomonia
2.Subject who are sufferring from acute body disease
3.Subject who cannot receive yoga therapy according to the verbal instruction
4.Subject who cannot do night electroencephalography at home
5.Pregnant woman
6.subjects who regularly use relaxation techniques such as yoga, autonomic training, gradual muscle relaxation, etc.
7.Subject who have a night shift or a shift on the week before study participation and on the day of the EEG test for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sachiyo |
| Middle name | |
| Last name | Morita |
Organization
Shiga University of Medical Science
Division name
Cancer center/Dept. Psychiatry
Zip code
5202192
Address
Seta tsukinowacho, Otsu city, Shiga, JAPAN
TEL
0775482291
sasa@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Sachiyo |
| Middle name | |
| Last name | Morita |
Organization
Shiga University of Medical Science
Division name
Cancer center/Dept.Psychiatry
Zip code
5202092
Address
Seta tsukinowacho, Otsu city, Shiga, JAPAN
TEL
0775482291
Homepage URL
sasa@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Ethics Committee of Shiga University of Medical Science
Address
Seta tsukinowacho, Otsu city, Shiga, JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2023 | Year | 03 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044539
