Impact of Comparing Treatment Status With Other CPAP Users

NCT07124975 | Enrolling By Invitation

• 1 other identifier: C1736
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea; Obstructive Sleep Apnea

Keywords

CPAP adherence

Outcome Measures

Primary Outcomes (1)

• Number of participants with improvement in CPAP adherence

  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 Outcomes (3)

• CPAP adherence

  6 months

• CPAP adherence

  6 months

• daytime sleepiness

  6 months

Study Arms (2)

Routine treatment data feedback group

ACTIVE COMPARATOR

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

Treatment data comparison group

EXPERIMENTAL

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

Interventions

Comparison of the treatment data with other patients 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.

Treatment data comparison group

CPAP data feedback 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.

Routine treatment data feedback group; Treatment data comparison group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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.
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Kimihiko Murase: lead

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 6068507, Japan

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

JP (1)