UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006012 |
|---|---|
| Receipt number | 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 16:39:14 |
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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
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
Sponsor or person
Institute
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007108
