At a glance
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Effects of an Early Combination of Automated Electronic and Telemedical Support on the Therapeutic Results of CPAP and APAP Patients and as a Supplement to (Tele-) Medical Care
In Brief
A clinical study evaluating digital patient support for Obstructive Sleep Apnea and Adherence, Treatment. Completed, enrolled 100 participants across 1 site.
Detailed Summary
Obstructive sleep apnea (OSA) is a type of sleep-related breathing disorders that is characterized by a sleep-related constriction (obstruction) of the upper airways. The treatment with continuous application of positive airway pressure (CPAP) via respiratory mask forms the therapeutical standard of OSA. The autoCPAP (automatic positive airway pressure: APAP) therapy is an additional treatment option for patients with more unstable conditions (e.g. due to sleep position) which is characterized by a dynamic adaption of the applied airway pressure according to patients therapeutical needs. Device usage time and therapy adherence are crucial for treatment success. The purpose of this study is to assess the effect of a digital patient support (DPS) tool, complementary to standard care on continuous and automatic positive airway pressure (CPAP, APAP) 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 are prospectively included and randomized to receive standard care (SC) or standard care with personalized DPS via prisma APP prototype version (SC+DPS). In both arms, initiation of therapy and standardized therapy control after 12 weeks is carried out identically. Patients in the SC+DPS arm received additionally automated feedback on their therapy and motivational messages, as well as therapy recommendations.
Study Details
Timeline
Interventions
Intervention takes place through a regular electronic therapy support in addition to standard care that is defined as follows: Emails to patients with personalized, automated feedback on their therapy (derived from device data received via modem or data entered by the patient via electronic questionnaire), 1. electronic questionnaires (web-based) on possible problems during therapy and subjective therapy success, 2. possibility to set personal adherence goals every week, 3. links to explanations and videos on therapy and the handling of therapy equipment and accessories, 4. provision of data for the trial center in the event of contact by the patient, as well as for routine therapy monitoring.