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Effects of Telemedical Support on Therapeutic Results of CPAP Patients

NCT05440279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-30

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

digital patient support

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.

Sponsors & Collaborators

  • Heinen und Löwenstein GmbH & Co. KG

    collaborator INDUSTRY

  • Facharztzentrum Sonneberg-Coburg uBAG

    lead OTHER

Principal Investigators

  • Christian Franke, Dr.med. · Facharztzentrum Sonneberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2021-11-03
Completion
2022-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440279 on ClinicalTrials.gov