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Enrolling by invitationNCT07124975Updated Dec 29, 2025

Impact of Comparing Treatment Status With Other CPAP Users

An interventional study of Comparison of the treatment data with other patients and CPAP data feedback in Sleep Apnea and Obstructive Sleep Apnea, sponsored by Kimihiko Murase. Enrolling by invitation at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Kimihiko Murase · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Apnea
  • Obstructive Sleep Apnea

Keywords

  • CPAP adherence
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's planned enrollment of 186 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

This is the only study on the registry with Kimihiko Murase as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
186 participants (estimated)

Study arms

  • 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

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

Interventions

  • BehavioralComparison 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.

  • BehavioralCPAP 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.

06

What researchers measure

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.

    Time frame: 6 months from the start of the interventions

Secondary outcomes

  1. CPAP adherence

    Change in the proportion of days with \>=4 hours of CPAP use

    Time frame: 6 months

  2. CPAP adherence

    Change in the average daily usage time

    Time frame: 6 months

  3. daytime sleepiness

    Daytime sleepiness will be assessed using a questionnaire at the start and end of the intervention.

    Time frame: 6 months

07

Study locations

1 site
  • Kyoto University Hospital
    Kyoto, Kyoto 6068507, Japan
08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07124975
Lead sponsor
Kimihiko Murase
Responsible party
Kimihiko Murase (Assistant Professor, Kyoto University Hospital) — Sponsor-investigator
First posted
Aug 15, 2025
Start date
Oct 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Dec 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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