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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010608
Receipt No. 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

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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
Email

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
Email tsuboit@skyoto.hosp.go.jp

Sponsor
Institute Department of Respiratory Medicine, Natonal Hospital Orgnization MInami-Kyoto Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012403

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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