“Benefits of osteopathic treatment in combination with orofacial exercises in addition to standard therapy for obstructive sleep apnea with breathing mask- a controlled, randomized study.”

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036547

Enrollment

Registered

2025-04-07

Start date

2025-04-14

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G47.31

Interventions

Group 1: Group 1, Myofascial Exercises and APAP Treatment 1. Soft palate Phonate an 'A' intermittently and continuously for a total of 3 minutes a day, alternating between the two. 2. Tongue a) 20 ti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >18 years, BMI<40kg/m2, OSAS diagnosis by PSG, sufficient knowledge of the German language in word and writing

Exclusion criteria

Exclusion criteria: craniofacial malformations, medications that affect the central nervous system, neuromuscular disorders, heart failure, pacemakers, tongue pacemakers, severe obstructive nasal diseases, severe mental illnesses, drug and alcohol abuse, pregnancy

Design outcomes

Primary

Measure	Time frame
1. Epworth Sleepiness Scale (ESS) The ESS is a measuring instrument for recording subjective daytime sleepiness in the diagnosis and therapy of OSAS. The measured values range from 0-24, a value >10 is considered increased daytime sleepiness requiring clarification. The questionnaire is completed before the first and after the last treatment.	—

Secondary

Measure	Time frame
1. HRV The data is collected via ECG (CardioSecur) and analyzed using Kubios HRV Scientific. The measurement is taken using an iPhone/iPad interface with a lightning connector. The data is exported from the iPhone/iPad for analysis in Kubios HRV Scientific. The 'HRV Breathing Pattern' app is used to set paced breathing in the ranges 6, 8, 10, 12, 14, 16, 18 breaths per minute (bpm), adjusting the HF bandwidth to assess respiratory sinus arrhythmia (RSA). Two measurement points are set: 1. before the first treatment 2. after the fourth treatment 2. APAP pressure The subjects are all supplied with APAP devices that automatically log the required pressure. The protocol is read out before the first and after the last treatment.	—

Measure

Time frame

1. HRV The data is collected via ECG (CardioSecur) and analyzed using Kubios HRV Scientific. The measurement is taken using an iPhone/iPad interface with a lightning connector. The data is exported from the iPhone/iPad for analysis in Kubios HRV Scientific. The 'HRV Breathing Pattern' app is used to set paced breathing in the ranges 6, 8, 10, 12, 14, 16, 18 breaths per minute (bpm), adjusting the HF bandwidth to assess respiratory sinus arrhythmia (RSA). Two measurement points are set: 1. before the first treatment 2. after the fourth treatment 2. APAP pressure The subjects are all supplied with APAP devices that automatically log the required pressure. The protocol is read out before the first and after the last treatment.

—

Countries

Germany

Contacts

Public ContactTobias Schmidt

Osteopathie Schule Deutschland

osd@osteopathie-schule.de+494064415690

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026