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


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 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


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

Value
https://center6.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