Impact of Comparing Treatment Status With Other CPAP Users

NCT ID: NCT07124975

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea Obstructive Sleep Apnea

Keywords

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CPAP adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CPAP data feedback

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Comparison of the treatment data with other patients

Intervention Type BEHAVIORAL

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.

CPAP data feedback

Intervention Type BEHAVIORAL

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

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kimihiko Murase

OTHER

Sponsor Role lead

Responsible Party

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Kimihiko Murase

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

Other Identifiers

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C1736

Identifier Type: -

Identifier Source: org_study_id