UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058037 |
|---|---|
| Receipt number | R000066337 |
| Scientific Title | The Impact of Comparing Treatment Status with Other Patients on Adherence to CPAP Therapy (CPAP-League Trial) |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/08/29 16:48:59 |
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Basic information
Public title
The Impact of Comparing Treatment Status with Other Patients on Adherence to CPAP Therapy (CPAP-League Trial)
Acronym
CPAP League Trial
Scientific Title
The Impact of Comparing Treatment Status with Other Patients on Adherence to CPAP Therapy (CPAP-League Trial)
Scientific Title:Acronym
CPAP League Trial
Region
| Japan |
Condition
Condition
Sleep apnea
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of the study is to examine whether adherence to CPAP treatment improves in patients with SAS who have been undergoing CPAP therapy for a long period by showing them the treatment status of other patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of participants who demonstrated improved CPAP adherence when comparing pre- and post-intervention periods.
CPAP adherence during the six months following initiation of the intervention will be compared with adherence during the three months before obtaining consent. Improvement in adherence will be defined as meeting either of the following criteria: (1) an increase of >=10% in the proportion of days with >=4 hours of CPAP use, or (2) an increase of >=40 minutes in the average daily usage time.
The observation period after the intervention is six months.
Key secondary outcomes
1. The proportion of days with >= 4 hours of CPAP use
2. Average daily CPAP usage time
3. Daytime sleepiness assessed using a questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Participants will receive monthly feedback on their CPAP therapy treatment data (usage time and the proportion of days with >4 hours of use) via mail or email for 6 months.
Interventions/Control_2
1. Participants will receive monthly feedback on their CPAP therapy treatment data (usage time and the proportion of days with >4 hours of use) via mail or email for 6 months.
2. The CPAP therapy treatment data of all study participants will be aggregated, and each participant will be ranked among the participants based on their treatment adherence. The results of the aggregations and the ranking will be provided as feedback to each participant every month.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. CPAP therapy has been initiated for SAS, diagnosed according to Japanese public health insurance criteria (apnea hypopnea index (AHI) >= 20/h by polysomnography, or respiratory event index (REI) is equal to or more than 40/h by portable monitoring device at the time of OSA diagnosis).
2. The patient is regularly attending outpatient visits to maintain CPAP therapy, in accordance with Japanese public health insurance requirements.
3. At least three months have passed since the introduction of the CPAP telemonitoring system.
Key exclusion criteria
A) Treatment adherence is already sufficiently good, with little need for further improvement. (Defined as a proportion of days with >4 hours of CPAP use of 90% or higher, and an average daily usage time >=7 hours over the past three months.)
B) No CPAP usage at all during the past three months (for example, due to business trips, caring for family members, or other social reasons resulting in an inability to use CPAP, and for whom improvement in adherence through this intervention is not expected).
C) Working night shifts twice or more a week.
D) Patients with cognitive impairment
Target sample size
186
Research contact person
Name of lead principal investigator
| 1st name | Kimihiko |
| Middle name | |
| Last name | Murase |
Organization
Graduate School of Medicine, Kyoto University
Division name
Departement of Respiratory Medicine
Zip code
606-8507
Address
54 Kawaharacho Syogoin Sakyo Kyoto
TEL
0757513852
kyodaisuimin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kimihiko |
| Middle name | |
| Last name | Murase |
Organization
Graduate School of Medicine, Kyoto University
Division name
Departement of Respiratory Medicine
Zip code
606-8507
Address
54 Kawaharacho Syogoin Sakyo Kyoto
TEL
0757513852
Homepage URL
kyodaisuimin@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Kawaharacho Shogoin Sakyo Kyoto
Tel
0753667618
ethcom@kuhp.kyoto-u.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
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 25 | 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
| 2025 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066337
