UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051874 |
|---|---|
| Receipt number | R000059187 |
| Scientific Title | Actual clinical practice of patients with sleep apnea syndrome (SAS) and persistence in continuous positive airway pressure (CPAP) therapy: A longitudinal study of real-world data |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2023/08/09 16:16:04 |
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Basic information
Public title
Actual clinical practice of patients with sleep apnea syndrome (SAS) and persistence in continuous positive airway pressure (CPAP) therapy: A longitudinal study of real-world data
Acronym
Actual clinical practice of patients with sleep apnea syndrome (SAS) and persistence in continuous positive airway pressure (CPAP) therapy
Scientific Title
Actual clinical practice of patients with sleep apnea syndrome (SAS) and persistence in continuous positive airway pressure (CPAP) therapy: A longitudinal study of real-world data
Scientific Title:Acronym
Actual clinical practice of patients with sleep apnea syndrome (SAS) and persistence in continuous positive airway pressure (CPAP) therapy
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Cardiology | Pneumology | Psychiatry |
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective 1: To understand patient demographics and actual clinical practice among patients who have newly started SAS treatment.
Objective 2: To investigate the duration of CPAP therapy and predictors for persistence among patients who have started CPAP therapy.
Basic objectives2
Others
Basic objectives -Others
Actual clinical practice
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Patient demographics and actual clinical practice in patients who have started SAS treatment
2. Treatment duration and predictors for persistence in patients who have started CPAP therapy
1) Duration of CPAP therapy
2) Predictors for persistence in CPAP therapy
3) Actual clinical practice in patients who have dropped out of CPAP therapy
4) Changes in body weight after CPAP therapy
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for Objective 1:
1.Patients who started SAS treatment under the code for diagnosis of SAS from April 2015 to February 2021
2.Patients traceable during the look-back period (365 days prior to the index date, the date on which SAS treatment was started)
3.Patients 18 years old and over in the index month (the month in which SAS treatment was started)
4.Insurance subscribers who have obtained permission to use dental claims data
Inclusion criteria for Objective 2:
1.Patients who started CPAP therapy only, without other therapy, on the index date and were among the study population for Objective 1
Key exclusion criteria
Exclusion criteria for Objective 1:
1.Patients with a history of SAS treatment during the look-back period
Exclusion criteria for Objective 2:
None
Target sample size
13000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
tpm-com@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
Homepage URL
tpm-com@umin.ac.jp
Sponsor or person
Institute
Teijin Pharma Limited
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
Teijin Pharma Limited
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
Tel
03-3506-4140
tpm-com@umin.ac.jp
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
| 2023 | Year | 08 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a longitudinal study using the DeSC database.
Management information
Registered date
| 2023 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059187
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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