Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study

Inclusion rate

Number of enrolled participants divided by the duration of the recruitment period, expressed as participants per month. The recruitment period is defined as the time from enrollment of the first participant to enrollment of the last participant.

Time frame: Through study completion, an average of one month

Recruitment Source Distribution

Proportion of participants enrolled via each recruitment route (diabetes outpatient clinic, general practice, patient-organisation/social media), reported as frequencies.

Time frame: Assessed after inclusion of the last participant

Proportion of Participants Obtaining Three Nights With Analyzable Recordings

Number of participants obtaining three nights of home monitoring with analyzable recordings from all devices scheduled for each night (NightOwl and SleepImage on nights 1-2; NightOwl, SleepImage and Nox T3 on night 3), divided by the number enrolled, expressed as a percentage.

Time frame: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment

Additional Test Nights Required to Obtain Three Analyzable Nights Among Participants Completing Home Monitoring

Among participants obtaining three nights with analyzable recordings from all devices scheduled for that night, the total number of home monitoring nights attempted. A night is repeated with all scheduled devices if the recording from one or more of these devices fails, is incomplete, or is non-analyzable, as assessed against predefined technical criteria. Reported as mean (SD) and median (range) nights attempted, and as the proportion of these participants requiring more than three nights. Participants declining further attempts before three analyzable nights were obtained are reported under outcome 8.

Time frame: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment

Number of Test Night Attempts Before Participant Discontinuation

Among participants who declined further attempts before three analyzable nights were obtained, the number of nights attempted at discontinuation. Reported as mean (SD) and median (range) attempts, together with the number and proportion of enrolled participants discontinuing before obtaining three analyzable nights. This outcome and outcome 7 comprise complementary, mutually exclusive groups, together accounting for all participants who started home monitoring.

Time frame: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment

Completeness of Baseline Assessments

Completeness of planned baseline assessments, reported as the proportion of participants with fully complete baseline data across all assessments and as the proportion completed per individual assessment (Berlin Questionnaire, STOP-Bang, Epworth Sleepiness Scale, ENT examination with flexible endoscopy, measuremen neck, waist and hip circumference, autonomic neuropathy assessment, blood pressure, lipids, HbA1c).

Time frame: Baseline (first visit).