UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005989 |
|---|---|
| Receipt number | R000007086 |
| Scientific Title | the study of "the effect of the psychotropic (hypnotic) drug on sleep quality, cognitive function and daily activity in patients with chronic hypercapnic respiratory failure who have received nocturnal noninvasive positive pressure ventilation for a long time." |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2013/07/21 10:34:05 |
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Basic information
Public title
the study of "the effect of the psychotropic (hypnotic) drug on sleep quality, cognitive function and daily activity in patients with chronic hypercapnic respiratory failure who have received nocturnal noninvasive positive pressure ventilation for a long time."
Acronym
the effect of the hypnotics on sleep in hypercapnic patients receiving nocturnal NPPV
Scientific Title
the study of "the effect of the psychotropic (hypnotic) drug on sleep quality, cognitive function and daily activity in patients with chronic hypercapnic respiratory failure who have received nocturnal noninvasive positive pressure ventilation for a long time."
Scientific Title:Acronym
the effect of the hypnotics on sleep in hypercapnic patients receiving nocturnal NPPV
Region
| Japan |
Condition
Condition
patients with chronic hypercapnic respiratory failure receiving a long-term noninvasive positive pressure ventilation (NPPV)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of hypnotics in patients receiving a long-term NPPV
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep quality, nocturnal transcutneous PCO2
Key secondary outcomes
subjective sleep quality, cognitive function and daily activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention 1:Zolpidem(5mg), one night => (one week) => placebo, one night
Interventions/Control_2
Intervention 2:placebo, one night =>(one week) => Zolpidem(5mg), one night
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) chronic hypercapnic respiratory failure
(2) receiving a long-term NPPV (more than 2 months)
(3) Clinically stable
Key exclusion criteria
(1) Clinically unstable
(2) Unable to discontinue hypnotics
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomasa Tsuboi |
Organization
Natonal Hospital Orgnization Minami-Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomasa Tsuboi |
Organization
Natonal Hospital Orgnization Minami-Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
Homepage URL
tsuboit@skyoto.hosp.go.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Natonal Hospital Orgnization MInami-Kyoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Center of Natonal Hospital Orgnization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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 | 08 | Month | 01 | 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 | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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 | 17 | Day |
Last modified on
| 2013 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007086
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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