Impact of Comparing Treatment Status With Other CPAP Users

December 21, 2025 updated by: Kimihiko Murase

Impact of Comparing Treatment Status With Other Patients on Treatment Adherence in CPAP Therapy.

The objective of this study is to evaluate whether comparing a patient's own CPAP usage data with that of other patients improves CPAP adherence in patients who have been undergoing long-term CPAP therapy for sleep apnea. Eligible participants are patients who have been on CPAP therapy with remote monitoring of treatment data enabled for at least three months. Participants will be randomly assigned to one of two groups: (1) routine treatment data feedback group, or (2) treatment data comparison group. In both groups, feedback will be provided to participants by mail on monthly basis, including the proportion of days with CPAP usage ≥4 hours per day and the average daily CPAP usage time. In the treatment data comparison group, in addition to this information, aggregated results for all participants (proportion of days with CPAP usage ≥4 hours per day and average daily usage time) and the participant's ranking based on these aggregated data will also be provided as feedback. The observation period will be six months after initiation of the intervention, and changes in treatment adherence before and after the intervention will be assessed.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kyoto
      • Kyoto, Kyoto, Japan, 6068507
        • Kyoto University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Eligibility criteria:

  • The patient has been diagnosed with SAS and has initiated CPAP therapy according to the criteria of Japanese public health insurance system(i.e., Apnea hypopnea index (AHI) >= 20/h by polysomnography, or respiratory event index (REI) is >= 40/h by portable monitoring device at the time of OSA diagnosis).
  • The patient makes regular outpatient visits for the continuation of CPAP therapy according to the requirements for the coverage of Japanese public health insurance.
  • At least three months have passed since the introduction of a CPAP remote monitoring system, and the researchers can confirm CPAP adherence online.
  • The patient has mailing address necessary for sending feedback by post or email.

Exclusion Criteria:

  • 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 month.)
  • No CPAP usage at all during the past 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).
  • Working night shifts twice or more a week.
  • Patients with cognitive impairment

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:(1) Average daily CPAP usage time in the previous month, and (2) 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: (3) Mean daily CPAP usage time among all participants, (4) Percentage of days with CPAP usage ≥ 4 hours per day among all participants, and (5) Participant's rank among all participants based on average daily CPAP usage time.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment data comparison group
In this group, feedback will be provided as in the routine treatment data feedback group. In addition to this information, aggregated results for all participants (proportion of days with CPAP usage ≥4 hours per day and average daily usage time) and the participant's ranking based on these aggregated data will also be provided as feedback.
Behavioral: CPAP data feedback
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.
Behavioral: Comparison of the treatment data with other patients
In this group, feedback will be provided as in the routine treatment data feedback group. In addition to this information, aggregated results for all participants (proportion of days with CPAP usage ≥4 hours per day and average daily usage time) and the participant's ranking based on these aggregated data will also be provided as feedback.
Active Comparator: Routine treatment data feedback group
In this group, feedback will be provided to participants by mail on monthly basis, including the proportion of days with CPAP usage ≥4 hours per day and the average daily CPAP usage time.
Behavioral: CPAP data feedback
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with improvement in CPAP adherence
Time Frame: 6 months from the start of the interventions
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.
6 months from the start of the interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP adherence
Time Frame: 6 months
Change in the proportion of days with >=4 hours of CPAP use
6 months
CPAP adherence
Time Frame: 6 months
Change in the average daily usage time
6 months
daytime sleepiness
Time Frame: 6 months
Daytime sleepiness will be assessed using a questionnaire at the start and end of the intervention.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimihiko Murase

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

August 9, 2025

First Submitted That Met QC Criteria

August 9, 2025

First Posted (Actual)

August 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Due to ethical considerations, the study data will be available upon request by contacting the corresponding author. The corresponding author will verify whether the request is subject to confidentiality obligations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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