UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on sleep-disordered breathing of sleeping drugs
Title of the study (Brief title)	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	Naoki Sekiguchi
Organization	Ongata hospital
Division name	Psychiatry
Address	105 nishiterakatamachi ,hachiouji-city,Tokyo,Japan
TEL	042-651-3411
Email	pandanaoki0408@gmail.com

Public contact
Name of contact person	Naoki Sekiguchi
Organization	Ongata Hospital
Division name	Psychiatry
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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