Table 3 Outcomes, measurements and device used
Outcome | Parameter | Scaling | Scoring | Device or source |
|---|---|---|---|---|
Primary outcome | ||||
Change in slow wave sleep (SWS or N3) between before and after one month of CPAP treatment | slow wave sleep (SWS or N3) | Continuous (min) | Dreem 3 Headband | |
Secondary outcomes | ||||
Changes in the sleep stages (W, N1, N2 and REM) | Sleep stages (W, N1, N2 and REM) Total time spent in each sleep stage | Continuous (min) | Dreem 3 Headband | |
Sleep parameters | Sleep times Sleep efficiency Microarousals/ arousals | Continuous (min, %, index) | Dreem 3 Headband | |
Nocturnal oximetry | Mean nocturnal SaO2, Minimal nocturnal SaO2 ODI 3% | Continuous (%) | Oxymeter, Nonin1350 | |
Blood glucose levels | Continuous subcutaneous glucose level | Continuous (mg/dl) | FreeStyle Libre 2 (Abbott) | |
Daily physical activity | Steps Distance | Continuous (Steps count, km) | Garmin Vivofit 4 pedometer | |
Patient reported outcomes (PROMs) | ||||
Sleep Quality | Pittsburg sleep quality questionnaire | Continuous | 0 to 21 | MARS database |
Insomnia severity | ISI questionnaire | Continuous | 0 to 28 | |
Daytime Sleepiness | Epworth sleepiness scale (ESS) | Continuous | 0 to 24 | |
Quality of life | SF-36 questionnaire | Continuous | 0 to 100 | |
Morning/nightlife questionnaire | Patient chronotype score (tendency to sleep late or rise early) measured in the morning/early evening | Continuous | 16 to 86 | |
Treatment compliance and efficacy | Mean CPAP use (rAHI) | Continuous (h/night, events/h) | ||
Blood glucose | Blood glucose | Continuous (mmol/l) | Blood samples | |
Insulin | Insulin | Continuous (µUI/ml) | ||
HbA1c | HbA1c | Continuous (%) | ||
Lipid profile: Triglycerides, Cholesterol, LDL, HDL | lipid profile: Triglyceride, Cholesterol, LDL, HDL | Continuous (mmol/l) | ||