NCT05440279

Effects of Telemedical Support on Therapeutic Results of CPAP Patients

Completed NA Last updated 30 June 2022

What this trial tests

NA trial testing digital patient support in Obstructive Sleep Apnea in 100 participants. Completed in 31 March 2022.

Timeline

19 February 2019

Primary endpoint
3 November 2021

31 March 2022

Quick facts

Lead sponsor	Facharztzentrum Sonneberg-Coburg uBAG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	19 February 2019
Primary completion	3 November 2021
Estimated completion	31 March 2022
Sites	1 location across Germany

Drugs / interventions tested

• digital patient support

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
• Adherence, Treatment — all drugs for Adherence, Treatment →

Sponsor

Facharztzentrum Sonneberg-Coburg uBAG

Who can join

Adults 18 to 80, any sex, with Obstructive Sleep Apnea or Adherence, Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of a digital patient motivation and support tool on CPAP/APAP adherence and daytime sleepiness: a randomized controlled trial.
   Franke C, Piezonna F, Schäfer R, Grimm A, et al · · 2024 · cited 3× · PMID 38469583 · DOI 10.1007/s41105-023-00479-9