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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023654
Receipt No. 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

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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
Email 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
Email pandanaoki0408@gmail.com

Sponsor
Institute Ongata hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027231

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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