Sleep ApneaNCT07124975
Impact of Comparing Treatment Status With Other CPAP Users
A study testing Comparison of the treatment data with other patients and CPAP data feedback in people with Sleep Apnea and Obstructive Sleep Apnea, run by Kimihiko Murase at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive Sleep Apnea
- What is being tested?
- Comparison of the treatment data with other patients and CPAP data feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- If the patient's background and CPAP adherence over the previous month meet the inclusion criteria, informed consent will be obtained from the patient.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea
- Being tested
- Comparison of the treatment data with other patients, CPAP data feedback
- Keywords
- CPAP adherence
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of the treatment data with other patientsBehavioural
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 feedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Comparison of the treatment data with other patients; Behavioral: CPAP data feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months from the start of the interventions
Secondary outcomes (3)
CPAP adherence
Change in the proportion of days with >=4 hours of CPAP use
Measured: 6 months
CPAP adherence
Change in the average daily usage time
Measured: 6 months
daytime sleepiness
Daytime sleepiness will be assessed using a questionnaire at the start and end of the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kimihiko Murase
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kimihiko Murase, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124975
- Sponsor's protocol ID
- C1736
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Comparing Treatment Status With Other Patients on Treatment Adherence in CPAP Therapy.
- ClinicalTrials.gov ID
- NCT07124975
- Acronym / sponsor ID
- C1736
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea
- Keywords
- CPAP adherence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Kimihiko MuraseUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine treatment data feedback group | Active comparator | Behavioral: CPAP data feedbackIn 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 data comparison group | Experimental | Behavioral: Comparison of the treatment data with other patients, Behavioral: CPAP data feedbackIn 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of the treatment data with other patientsIn 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. | Behavioural | Treatment data comparison group |
| CPAP data feedbackParticipants 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. | Behavioural | Routine treatment data feedback group, Treatment data comparison group |
Primary outcome
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.
3 secondary outcomes
CPAP adherence
Time frame: 6 months
CPAP adherence
Time frame: 6 months
daytime sleepiness
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of the treatment data with other patients and CPAP data feedback in people with Sleep Apnea and Obstructive Sleep Apnea, run by Kimihiko Murase at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with improvement in CPAP adherence (time frame: 6 months from the start of the interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.