UMIN-CTR Clinical Trial

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

Sleep apnea

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The primary outcome is the number of participants whose CPAP adherence improves after the intervention compared with baseline. Improvement in CPAP adherence is defined as either: an increase of more than or equal to 10% in the proportion of days with more than or equal to 4 hours of CPAP use per day, or an increase of more than or equal to 30 minutes in the average daily CPAP usage time, comparing the 6-month intervention period to the month preceding consent acquisition.

Key secondary outcomes

The following variables will be assessed as secondary outcomes:

1. Change in the proportion of days with more than or equal to 4 hours of CPAP use between the month preceding informed consent and the 6-month intervention period.

2. Change in average daily CPAP usage time between the month preceding informed consent and the 6-month intervention period.

3. Change in the proportion of days with more than or equal to 4 hours of CPAP use between the 3 months preceding informed consent and the 6-month intervention period.

4. Change in average daily CPAP usage time between the 3 months preceding informed consent and the 6-month intervention period.

5. Change in sleepiness from baseline (at enrollment) to 6 months after the intervention.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention Details
1 When a patient who is a potential participant visits the outpatient clinic for continued CPAP therapy, their CPAP adherence during the previous month will be checked.
2 If the patient's background and CPAP adherence over the previous month meet the inclusion criteria, informed consent will be obtained from the patient.
3 After the number of patients who have provided consent reaches the planned sample size, a postal item will be sent to confirm the accuracy of the participant's address. The mailing will include a postcard for reply or QR code that allows the research team to verify that the participant has received the item. Participants whose receipt of the mailing can be confirmed will be eligible for randomization.
4 Participants will be randomly assigned to either the control group (receiving only information about their own CPAP adherence) or the peer comparison group (receiving information about their own adherence plus the summary of adherence data from all participants).
5 Thereafter, for six months, participants will receive by mail monthly information about their CPAP adherence. Each mailing will include a postcard for reply and a QR code that allow participants to notify the researchers that they have opened the mailing.

In the control group, the following information will be provided: A. Average daily CPAP usage time in the previous month, and B. Percentage of days with CPAP usage more than or equal to 4 hours per day. In the peer comparison group, in addition to the above, the following information will be provided: C. Mean daily CPAP usage time among all participants, D. Percentage of days with CPAP usage more than or equal to 4 hours per day among all participants, and E. Participant's rank among all participants based on average daily CPAP usage time.

Interventions/Control_2

IIntervention Details
1 When a patient who is a potential participant visits the outpatient clinic for continued CPAP therapy, their CPAP adherence during the previous month will be checked.
2 If the patient's background and CPAP adherence over the previous month meet the inclusion criteria, informed consent will be obtained from the patient.
3 After the number of patients who have provided consent reaches the planned sample size, a postal item will be sent to confirm the accuracy of the participant's address. The mailing will include a postcard for reply or QR code that allows the research team to verify that the participant has received the item. Participants whose receipt of the mailing can be confirmed will be eligible for randomization.
4 Participants will be randomly assigned to either the control group (receiving only information about their own CPAP adherence) or the peer comparison group (receiving information about their own adherence plus the summary of adherence data from all participants).
5 Thereafter, for six months, participants will receive by mail monthly information about their CPAP adherence. Each mailing will include a postcard for reply and a QR code that allow participants to notify the researchers that they have opened the mailing.

In the control group, the following information will be provided: A. Average daily CPAP usage time in the previous month, and B. Percentage of days with CPAP usage more than or equal to 4 hours per day. In the peer comparison group, in addition to the above, the following information will be provided: C. Mean daily CPAP usage time among all participants, D. Percentage of days with CPAP usage more than or equal to 4 hours per day among all participants, and E. Participant's rank among all participants based on average daily CPAP usage time.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 1 month.)
B) No CPAP usage at all during the past 1 month (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

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

Email

kyodaisuimin@kuhp.kyoto-u.ac.jp

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

Email

kyodaisuimin@kuhp.kyoto-u.ac.jp

Institute

Kyoto university

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

54 Kawaharacho Shogoin Sakyo Kyoto

Tel

0753667618

Email

ethcom@kuhp.kyoto-u.ac.jp

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

Date of disclosure of the study information

2025

Year

06

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

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 related information

Registered date

2025

Year

06

Month

01

Day

Last modified on

2025

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066337