UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010608 |
|---|---|
| Receipt number | R000012403 |
| Scientific Title | the study of "the effect of the psychotropic (hypnotic) drugs, antipsychotic drugs, and/or antidepressant drugs on clinical symptoms, sleep quality, cognitive function, daily activity, health related quality of life, and survival in patients with chronic hypercapnic respiratory failure who have received long-term oxygen therapy and/or nocturnal noninvasive positive pressure ventilation for a long time." |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2013/04/29 00:54:26 |
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Basic information
Public title
the study of "the effect of the psychotropic (hypnotic) drugs, antipsychotic drugs, and/or antidepressant drugs on clinical symptoms, sleep quality, cognitive function, daily activity, health related quality of life, and survival in patients with chronic hypercapnic respiratory failure who have received long-term oxygen therapy and/or nocturnal noninvasive positive pressure ventilation for a long time."
Acronym
the effect of the psychotropics on clinical course in patients with chronic hypercapnic respiratory failure
Scientific Title
the study of "the effect of the psychotropic (hypnotic) drugs, antipsychotic drugs, and/or antidepressant drugs on clinical symptoms, sleep quality, cognitive function, daily activity, health related quality of life, and survival in patients with chronic hypercapnic respiratory failure who have received long-term oxygen therapy and/or nocturnal noninvasive positive pressure ventilation for a long time."
Scientific Title:Acronym
the effect of the psychotropics on clinical course in patients with chronic hypercapnic respiratory failure
Region
| Japan |
Condition
Condition
patients with chronic hypercapnic respiratory failure receiving a long-term oxygen therapy and/or noninvasive positive pressure ventilation (NPPV)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of hypnotics on clinical symptoms, health related quality of life, ABGs, pulmonary function, and survival in patients receiving a long-term oxygen therapy and/or long-term NPPV
Basic objectives2
Others
Basic objectives -Others
To elucidate the prevalence of prescription of hypnotics in patients receiving a long-term oxygen therapy and/or long-term NPPV
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Effect of habitual intake of hypnotics on ABGs, especially PaCO2
Key secondary outcomes
(1) Effect of habitual intake of hypnotics on hospitalization rate and hospitalization length due to respiratory deteriolation.
(2) Effect of habitual intake of hypnotics on prognosis.
(3) Relationships between habitual intake of hypnotics and other factors such as health related quality of life.
(4) Investigation of the prevalence of prescription of hypnotics in patients receiving a long-term oxygen therapy and/or long-term NPPV.
(5) Investigation of subjective preference of hypnotics.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients receiving long-term oxygen therapy and/or long-term NPPV
Key exclusion criteria
Patients who do not agree to participate in this study.
Patients who can not understand our questionnaire.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomasa Tsuboi |
Organization
National Hospital Organization 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
National Hospital Organization 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
| 2013 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Medication, age, hight, weight, disease, ABGs, hospitalization rate, HRQOL and others are examined.
Management information
Registered date
| 2013 | Year | 04 | Month | 29 | Day |
Last modified on
| 2013 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012403
