UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023654 |
|---|---|
| Receipt number | R000027231 |
| Scientific Title | Effects on sleep-disordered breathing of sleeping drugs |
| Date of disclosure of the study information | 2016/08/17 |
| Last modified on | 2016/08/17 15:40:32 |
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Basic information
Public title
Effects on sleep-disordered breathing of sleeping drugs
Acronym
Effects on sleep-disordered breathing of sleeping drugs
Scientific Title
Effects on sleep-disordered breathing of sleeping drugs
Scientific Title:Acronym
Effects on sleep-disordered breathing of sleeping drugs
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Percutaneous oxygen saturation of the night in the sleep of patients who are using sleeping pills for the treatment of insomnia in our hospital to measure, examine the relevance of the sleeping pills and the nighttime breathing disorder, proper sleeping pills It aims at establishing usage of.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Transcutaneous oxygen saturation of the night in bed before and after the administration of sleeping pills
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient obtained the consent you are taking psychotropic drugs, including sleeping pills
Key exclusion criteria
Patients who did not get the consent. Patients who offer the consent withdrawal.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Sekiguchi |
Organization
Ongata hospital
Division name
Psychiatry
Zip code
Address
105 nishiterakatamachi ,hachiouji-city,Tokyo,Japan
TEL
042-651-3411
pandanaoki0408@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Sekiguchi |
Organization
Ongata Hospital
Division name
Psychiatry
Zip code
Address
105 nishiterakatamachi ,hachiouji-city,Tokyo,Japan
TEL
042-651-3411
Homepage URL
pandanaoki0408@gmail.com
Sponsor or person
Institute
Ongata hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 17 | 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
Date of protocol fixation
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 08 | Month | 17 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027231
