Kyoto University Hospital
Kyoto, 6068507, Japan
NCT Number: NCT07124975
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Kyoto, 6068507, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Eligibility criteria:
Exclusion criteria
Intervention Details
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.
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.
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.
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.
Time frame: 6 months
Change in the proportion of days with >=4 hours of CPAP use
Time frame: 6 months
Change in the average daily usage time
Time frame: 6 months
Daytime sleepiness will be assessed using a questionnaire at the start and end of the intervention.
Kimihiko Murase
Other
Impact of Comparing Treatment Status With Other Patients on Treatment Adherence in CPAP Therapy.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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