UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024781
Receipt No. R000028390
Scientific Title Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Date of disclosure of the study information 2016/12/31
Last modified on 2016/11/07

* 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 Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Acronym Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Scientific Title Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Scientific Title:Acronym Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Region
Japan

Condition
Condition Cardiovascular Diseases
Classification by specialty
Cardiology Intensive care medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the determinants of sleep disorders, and the efficacy of sleep bandle in patients who admitted to cardiovascular care unit (CCU)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quality of sleep evaluated by patients themselves at second day morning after admission by using our original questionnaire based on the Richards-Campbell Sleep Questionnaire (RCSQ)(Subjective assessments)
Key secondary outcomes Quality of sleep evaluated by nurses during first night period after admission by using our original questionnaire (Objective assessments)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Sleep bandle
(Our original vesion based on the previous report by Patel et al)

<Reducing Sound> From 10 p.m. to 6 a.m.
1. Monitoring panels
2. Mechanical Supports
3. Phones
4. Voices from between healthcare providers and patients
5. Voices from between healthcare providers and families
6. Earplugs are provided to all patients

<Reducing Light> From 10 p.m. to 6 a.m.
1. Darken a room
2. Using a light at bedside, if nursing care is performed
3. Eye pads are provided to all patients

<Nursing care> From 10 p.m. to 6 a.m.
1. Shoud be avoided during above period
2. Time, place and date are told to patients every 8 hours
3. Pain scale is evaluated every 2 hours and its optimizatation is performed
4. Control sleep disorders and derilium

Interventions/Control_2 Control:without the sleep bandle
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
13 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1. Staying at CCU for more than 48 hours
2. Can understand the questionnars and fill the form
Key exclusion criteria 1. No emergency admission
2. Mechanical ventilation
3. Using IV sedative drugs
4. Dementia
5. Derilium at first day
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mika Ozaki
Organization National Cerebral and Cardiovascular Center
Division name Cardiovascular Care Unit
Zip code
Address 5-7-1 Fujishiro-dai,Suita,Osaka 565-8565,Japan
TEL 06-6833-5012
Email ozaki.mika@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Ozaki
Organization National Cerebral and Cardiovascular Center
Division name Cardiovascular Care Unit
Zip code
Address 5-7-1 Fujishiro-dai,Suita,Osaka 565-8565,Japan
TEL 06-6833-5012
Homepage URL
Email ozaki.mika@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Foundation
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Non profit foundation
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 国立循環器病研究センター/National Cerebral and Cardiovascular Center

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 31 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 Completed
Date of protocol fixation
2015 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 09 Day
Last follow-up date
2016 Year 09 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 10 Day
Last modified on
2016 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028390

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.