UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006012
Receipt No. R000007108
Scientific Title Does late morning wake-up affect sleep in the following night in patients with primary insomnia?
Date of disclosure of the study information 2011/07/20
Last modified on 2011/07/20

* 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 Does late morning wake-up affect sleep in the following night in patients with primary insomnia?
Acronym Does late morning wake-up affect sleep in the following night in patients with primary insomnia?
Scientific Title Does late morning wake-up affect sleep in the following night in patients with primary insomnia?
Scientific Title:Acronym Does late morning wake-up affect sleep in the following night in patients with primary insomnia?
Region
Japan

Condition
Condition Primary insomnia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether sleep variables (e.g. sleep latency and total sleep time) are inferior in the following night when patients woke up later than usual compared to those when they woke up as usual. In addition, to evaluate relationship between wake up time and weekday/end.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate whether sleep latency is significantly different in the following night when patients woke up later than usual compared to those when they woke up as usual.
Key secondary outcomes 1. To evaluate whether total sleep time is significantly different in the following night when patients woke up later than usual compared to those when they woke up as usual.
2. To evaluate whether bedtime is significantly different in the following night when patients woke up later than usual compared to those when they woke up as usual.
3. To evaluate whether there are differences in sleep parameters (e.g. sleep latency and total sleep time) between weekday and weekend.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Placebo (the database only from placebo groups will be used for the current study)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria All the patients randominzed in placebo group in the clinical study in patients with primary insomnia
Key exclusion criteria Patients who were not included in FAS were excluded
Target sample size 380

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Kawakami
Organization Graduate School of Medicine and Public Health, Kyoto University
Division name Department of Pharmacoepidemiology
Zip code
Address Yoshida Konoe-cho, Sakyo-ku Kyoto 606-8501, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Ogawa
Organization Graduate School of Medicine and Public Health, Kyoto University
Division name Department of Pharmacoepidemiology
Zip code
Address Yoshida Konoe-cho, Sakyo-ku Kyoto 606-8501, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 07 Month 20 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 No longer recruiting
Date of protocol fixation
2011 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 20 Day
Last modified on
2011 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007108

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.