Effect of a digital patient motivation and support tool on CPAP/APAP adherence and daytime sleepiness: a randomized controlled trial

Abstract

The purpose of this study was to assess the effect of a digital patient support (DPS) tool, complementary to standard care on continuous or automatic positive airway pressure (auto)CPAP adherence and daytime sleepiness after 12 weeks in patients diagnosed with severe obstructive sleep apnea (OSA). All patients with apnea-hypopnea index (AHI) ≥ 30 per hour were prospectively included and randomized to receive standard care (SC) or standard care with personalized DPS via a mobile app prototype version (SC + DPS). Patients in the SC + DPS arm received additionally automated feedback on their therapy, motivational messages and therapy recommendations. 100 patients completed the study (SC: 50, SC + DPS: 50). No differences were found in characteristics of SC vs. SC + DPS (mean ± SD) for age (53.9 ± 10.8 vs. 51.7 ± 12.3 years), initial diagnostic apnea-hypopnea index (51.1 ± 15.5 vs. 50.9 ± 17.7 events/h), BMI (33.8 ± 6.7 vs. 33.5 ± 4.5 kg/m), and Epworth Sleepiness Scale (ESS) baseline score (9.5 ± 4.2 vs. 9.1 ± 5.2). After 12 weeks, mean ESS score was significantly lower (SC: 7.6 ± 4.1 vs. SC + DPS: 5.5 ± 3.9; p = 0.006) in the SC + DPS group vs. standard care group. Therapy adherence was significantly higher (SC: 268.7 ± 122.1 vs. SC + DPS: 338.8 ± 106.8 min; p = 0.002) in the SC + DPS group compared to standard care group. No difference was found in the residual AHI between both groups. However, SC + DPS group showed a trend towards fewer phases with increased leakage compared to SC group. Intention-to-treat analysis (112 (56/56) patients) showed similar results. After 12 weeks, (auto)CPAP adherence and daytime sleepiness improved significantly in patients with severe OSA using the digital patient support tool. Clinical Trial Registration (retrospectively registered): Registry: NCT05440279; Title: Effects of Telemedical Support on Therapeutic Results of CPAP Patients; URL: https://clinicaltrials.gov/ct2/show/NCT05440279; Date of registration: June 30, 2022.

Supplementary information: The online version contains supplementary material available at 10.1007/s41105-023-00479-9.

Keywords: Adherence; Continuous positive airway pressure; Digital patient support; Obstructive sleep apnea; Prisma APP; Telehealth.

Fig. 1

Study flow chart. OSA obstructive sleep apnea; AHI apnea–hypopnea index; CPAP continuous positive airway pressure; APAP automatic positive airway pressure ESS Epworth Sleepiness Scale; FOSQ Functional Outcomes of Sleep Questionnaire

Fig. 2

App prototype screens. a Daily report: therapy feedback to patient per day with highlighted current day. Therapy duration per day. Advice for therapy duration. Last night usage, mean usage current week, personal goal achievement. Information about mask fitting, therapy efficacy and deep sleep. Links to supportive videos and websites. Link to share a summary of data with the sleep center. b Weekly report: therapy feedback to patient per day for the last week. Therapy duration and efficacy for completed week. Estimated duration of deep sleep. c Weekly evaluation: detailed information about weekly goal and current goal attainment. Link to set weekly goal. Detailed information about usage, mask fitting, therapy efficacy and deep sleep (with ranking). Hints to improve therapy. Link to therapy check. Links to supportive videos and websites. Link to share a summary of data with the sleep center

Fig. 3

Box plots illustrating ESS score at baseline and follow-up per study arm. Horizontal line within boxes depicts the median. Upper and lower box boundaries are 75th and 25th percentile, respectively. **p ≤ 0.01; ***p ≤ 0.001; ****p ≤ 0.0001

Fig. 4

Box plots illustrating adherence and device usage according to number of used days (> 4 h) after 12 weeks per study arm. Horizontal line within boxes depicts the median. Upper and lower box boundaries are 75th and 25th percentile, respectively. **p ≤ 0.01