Impact of Comparing Treatment Status With Other CPAP Users

Kimihiko Murase

Status: Invitation-only

Conditions: Sleep Apnea; Obstructive Sleep Apnea

Treatments: Behavioral: CPAP data feedback; Behavioral: Comparison of the treatment data with other patients

Study type: Interventional

Funder types: Other

Identifiers

NCT07124975

C1736

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Routine treatment data feedback group

Active Comparator group

Description:

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.

Treatment:

Behavioral: CPAP data feedback

Treatment data comparison group

Experimental group

Description:

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.

Treatment:

Behavioral: CPAP data feedback

Behavioral: Comparison of the treatment data with other patients