Imprint
Company Name
Snore Free GmbH
Business Purpose
Development and operation of digital business models including the production and trade of medical products, limited to medical device software
Registered Office and Address
Josefstädterstrasse 82/7/140, 1080 Vienna – Austria
Contact Details
E-Mail: office@schnarchfrei.de
Fone: +43 676 4760299
Managing Director
Sigismund Gänger
Commercial Register Court
Commercial Court Vienna
Commercial Register Number
FN 489833v
Competent Professional Association
WKO
Supervisory Authority
BASG – Bundesamt für Sicherheit im Gesundheitswesen
Applicable Legal Provisions and Access
Trade regulations www.bundeskanzleramt.gv.at
UID-Number
ATU73332119
Product information
The SchnarchFrei system
is a combination of the SchnarchFrei app and the SchnarchFrei UtilityPack (kit of utensils). The SchnarchFrei therapy is conducted through the app and uses accessories that are proven in speech therapy, which are provided in a separate package.
Medical Purpose
The SchnarchFrei System is intended for myofunctional therapy of pharyngeal insufficiency (organic tissue weakness in the mouth-throat-pharynx area) as an important cause of snoring (rhonchopathy) and obstructive sleep apnea syndrome (OSAS) for patients aged 18 and over.
Intended Use
The SchnarchFrei Therapy is designed to be used by medical laypersons in a non-clinical setting, e.g., at home. The software is suitable for patients aged 18 and over.
Proof of Efficacy
Proof of efficacy is a prerequisite for listing a digital health application (DiGA) in the directory of the Federal Institute for Drugs and Medical Devices (BfArM). SchnarchFrei demonstrated efficacy in a controlled randomized trial. Show results
Unique Device Identifier
UDI (01)04170000085836(8012)
Actor identification Eudamed
CE labeling
The SchnarchFrei therapy app is an approved Class I medical device.
Data Protection Information
See privacy policy
Instructions for Use
Information Security Policy
Information security is at the core of our company! Read our information security policy here: Informationssicherheitspolitik
Darstellung der Anwendung im Verzeichnis nach § 139e Absatz 1 SGB V im DiGA-Verzeichnis
Wird hier zu finden sein: https://diga.bfarm.de/de/verzeichnis
Sources of Medical Content
This list offers an insight into research and guidelines on snoring and sleep apnea, including S3 guidelines, literature, and clinical studies. It highlights diagnostics, therapy, and the latest treatment approaches, an important resource for professionals and those affected.
Studies
Two randomized controlled trials were conducted: one for OSAS (obstructive sleep apnea syndrome) and one for Rhonchopathy, each with 95 participants. The dropout rate was below 10%, and the observation period was 3 months starting in April 2023. The Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS) were used to measure outcomes.
Ergebnisbericht-Pilotstudie2023-OSAS.pdf
Ergebnisbericht-Pilotstudie2023-Rhonchopathie.pdf
Information on Interoperability
Here you will find a detailed specification for data exchange in health applications, based on the medical data structure according to MIO DiGA Toolkit 1.0.0: PDF Download
Image Sources
- Snore Free GmbH
- Shutterstock
- Pixabay
Technical Information
Minimum requirements for installing the SchnarchFrei App:
- iOS 14.1 or higher (iPhone, iPad, iPod Touch)
- Android 10.0 or higher (Smartphone, Tablet)
To download the app, your mobile device needs 70 MB of free storage; the entire training requires about 500 MB. To ensure the security of the app, using the SchnarchFrei App on devices with Jailbreak is not allowed.
Latest App Updates
- iOS: Version 1.0.* – February 2024
- Android: Version 1.0.* – February 2024