G47.31
Conditions
Interventions
Group 1: Arm 1 is the intervention group, which includes 95 patients. Suitable study participants are aged between 18 and 65 and suffer from obstructive sleep apnea syndrome.
Procedure:
Visit 0:
Soc
Sponsors
SNORE FREE GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. OSAS with standard therapy (ICD-10 G 47.31) with or without prescribed CPAP ventilation 2. ESS score of = 11 3. PSQI score of = 6 4. Age = 18 years – 65 years 5. Men and women, as well as non-binary genders 6. BMI = 30 kg/m2 7. The patient resides in Germany. 8. The patient has a valid telephone number, email address, and postal address. 9. Use of smartphones/tablets with operating system Android 10 or iOS 14.1 or higher 10. The patient must be able to understand the patient information: intellectual understanding, sufficient knowledge of German. 11. Written consent after receiving information (patient information)
Exclusion criteria
Exclusion criteria: 1. Mental, cognitive, or intellectual impairment or disability (low intelligence, mental retardation) 2. Persons with temporary or permanent deficits in their mental faculties or sensory perception, e.g., due to drugs, alcohol, or side effects of medication 3. Persons who do not have sufficient knowledge of the German language 4. Incapacity to give consent 5. Persons who are dependent on or employed by the sponsor or investigator 6. Placement in an institution due to a court or official order 7. Participation in another clinical trial in the same indication area 8. Use of another smartphone app in the same indication area or myofunctional or speech therapy treatments carried out in the last 6 months 9. Lack of documented medical diagnosis of OSAS 10. Sleep disorder and/or daytime sleepiness from an indication other than OSAS 11. Previous use of the Schnarchfrei system 12. Change in concomitant medication affecting daytime sleepiness and sleep quality in the last 3 weeks prior to inclusion 13. OSAS: Change in CPAP settings in the last 3 months 14. Planned or recent surgical intervention (within the last 3 months) affecting the head, neck, or throat area 15. Prolonged absence during the study period (3 months) with a possible effect on standard therapy, time changes, or inability to complete electronic questionnaires 16. Medical history: all organic comorbidities and disorders that also cause snoring or airway obstruction during sleep, such as nasal polyps, nasal allergies, chronic rhinitis, sinusitis, enlarged palatine and pharyngeal tonsils (tonsils, adenoids), other nasal obstructions (e.g., enlarged turbinates), hypertrophic (enlarged) tongue base, organically enlarged soft palate (velum hyperplasia, webbing), severely receded lower jaw (retrogenia) 17. Extrapyramidal diseases and movement disorders (e.g., Parkinson's disease), 18. Systemic atrophies predominantly of the central nervous system (e.g., spinal muscular atrophy, Huntington's disease), 19. Cerebral palsy and other paralysis syndromes (especially if they relate to the oropharyngeal area), 20. Demyelinating diseases of the central nervous system and movement disorders (such as multiple sclerosis) 21. Taking allergy, sleep, or sedative medication during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint includes the change in daytime sleepiness at time T2 after 12 weeks of treatment with the investigational product in addition to standard therapy versus the control group receiving standard therapy alone, as measured by the Epworth Sleepiness Scale (Bloch et al., 1999). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: • Improvement in sleep quality • Reduction in AHI score • Reduction in oxygen desaturations • Improvement in respiratory disturbance index • Improvement in CPAP adherence • Improvement in mental health • Complications, events | — |
Countries
Germany
Contacts
Public ContactUso Walter
HNO-Gemeinschaftspraxis van Ackeren und Zander
Outcome results
None listed