“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.”
Organizational Data
- DRKS-ID:
- DRKS00036547
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2025-04-07
- Last update in DRKS:
- 2025-04-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
OSAS and heart rate variability (HRV)Obstructive sleep apnoea syndrome (OSAS) is a widespread sleep-related breathing disorder and affects around 2% of women and 4% of men >50 years of age. The course is often asymptomatic, so that a high number of unreported cases must be assumed.Untreated OSAS is a risk factor for overall mortality and increases with the severity of the disease.OSAS is considered a risk factor for diseases of the cardiovascular system, e.g. hypertension, cardiac arrhythmias, coronary heart disease, heart failure and sudden cardiac death.It is assumed that OSAS leads to a disturbance in the autonomic variability of cardiovascular function. This increases the risk of developing cardiovascular diseases.As the AHI only reflects the respiratory part of OSAS, the establishment of further objective markers for monitoring the course of therapy is advocated, in particular HRV as a marker for autonomic cardiac regulation.OSAS and myofunctional therapyVarious studies have shown that a daily exercise routine for the oropharyngeal muscles resulted in an improvement in the AHI.OSAS and osteopathyThe aim is to investigate whether a routine consisting of treatment of the cranial dura via falx cerebri and cerebelli and tentorium cerebelli, the jugular foramen and the atlanto-occipital region has a positive influence on autonomic cardiac regulation. This could be evaluated via an improved AHI in a group comparison.
Health condition or problem studied
- ICD-10-GM (translation):
- G47.31 - Obstructive sleep apnea syndrome
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Group 1, Myofascial Exercises and APAP Treatment1. Soft palatePhonate an 'A' intermittently and continuously for a total of 3 minutes a day, alternating between the two.2. Tonguea) 20 times, 3 times a day, place the tongue behind the upper incisors, slide it from there to the soft palate and 'massage' it with the tongue for a few seconds.b) 20x, 3x daily, suck the tongue against the palate, hold for a few seconds, let it snap back.c) 20x, 3x daily, press the tongue against the floor of the mouth, hold for a few seconds, keeping contact with the lower incisors with the tip of the tongue.3. Facea) Press your lips together with your mouth closed, hold for 30 seconds, 3 times a day.b) Suck your cheeks and lips between your teeth 10 times, 3 times a day.c) Press your cheek outwards with your index finger inserted in your mouth, build up counter-tension with your cheek muscles, 10 times each side, 3 times a day.d) Move the lower jaw to the side and at the same time pull the corner of the mouth towards the ear on that side, 10 times each side, 3 times a day.e) Inflate a balloon, take 3 breaths without stopping, inhaling through the nose, 3 times a day.f) Chew one bite on the right and one bite on the left at each meal. Swallow with the tongue on the front palate and teeth closed.The participants keep a diary of the practice, which must be done on average at least 5 out of 7 days, otherwise they will be excluded from the study.The participants will be provided with additional video instructions for this.
- Arm 2:
- Group 2, Myofascial Exercises, Osteopathic Treatment and APAP TreatmentMyofascial Exercises see Group 1Osteopathic Treatment:1. OA-releaseThe patient is in a supine position, the practitioner at the head end.The patient's head lies on the practitioner's palms, the fingers are placed at right angles directly below the occiput and point anteriorly.As the neck muscles relax, it is possible to make contact with the arch of the atlas. This happens purely passively through the weight of the head. Now it is possible to use the ring and little fingers to release the occiput from the atlas by pulling it cranially, while the middle fingers fix the atlas.In the last step, decompression of the occipital condyles takes place as the practitioner moves his elbows towards each other.2. Dura mater treatment via the frontal and parietal bonea) Frontal bone spread/liftThe patient is in the supine position, with the practitioner at the head end.Both ring fingers, supported by the little fingers, hook into the zygomatic process of the frontal bone, while the index and middle fingers rest on the frontal bone to the side of the metopic suture. The palms rest on the head with crossed thumbs.A slight pressure is applied posteriorly using the index and middle fingers. This relaxes the anterior-posterior diameter of the falx cerebri.The resulting micromovements are followed until they are no longer perceptible and the frontal bone initiates an inward rotation.For the lift technique, the ring and little fingers first exert a slight medial pressure until the suture opens and then an anterior pull.The micromovements are followed again and at the end of the technique the pull is released again.b) Os parietale spread/liftThe patient is in a supine position, with the practitioner at the head end.The fingers of both hands are placed laterally on the head, with the index finger behind the coronal suture and the little finger in front of the asterion.The thumbs lie crossed on the skullcap, to the right and left of the sagittal suture.The thumbs exert a gentle pressure in the caudal direction, causing the falx cerebri to relax in the cranio-caudal direction.The rest of the treatment follows the pattern described above.For the lift technique, the hands slide cranially over the parietosquamous suture. The thumbs are no longer in contact with the skull, but remain over the sagittal suture.A slight medial pressure is applied until the suture releases and then a cranial pull is applied.3. Foramen jugulare treatment via the temporal boneThe patient is in the supine position, with the practitioner at the head end.The contralateral hand holds the occiput, near the occipito mastoid suture.The ipsilateral hand grasps the zygomatic process of the temporal bone with the thumb and index finger, the middle finger is in the external acoustic meatus, the ring finger on the mastoid process and the little finger on the pars mastoidea of the temporal bone.To treat the petroccipital suture, a slight pull is applied to the occiput in a contralateral direction until the suture separates. The temporal bone is then rotated anteriorly or posteriorly, following the tension, until the point of balanced membranous tension (PBMT) is reached.Then, to treat the petro-jugular suture, the temporal bone is rotated medially or laterally while maintaining the same hand position, again in search of the PBMT.The PBMT is defined as the point of greatest balance of the membranous tension between two structures. This is held by the therapist while allowing micro- or compensatory movements until, often after a still point at which no more movements can be felt, a new, breathing-like rhythm sets in.
- Arm 3:
- Group 3, APAP treatmentThis group will not receive any further intervention in addition to therapy with the breathing mask.
Endpoints
- Primary outcome:
- 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 outcome:
- 1. HRVThe 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 treatment2. after the fourth treatment2. APAP pressureThe 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
See Also
Hydrocodone/Apap 10/325mg tabRational Design of Novel Pyridinol-Fused Ring Acetaminophen AnaloguesELIVERA Group WorldWide United Kingdom since 1988Recruitment Locations
- Recruitment countries:
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
- Doctor's practice Hamburg
Recruitment period and number of participants
- Planned study start date:
- 2025-04-14
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 45
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Age >18 years, BMI<40kg/m2, OSAS diagnosis by PSG, sufficient knowledge of the German language in word and writing
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
Addresses
Primary Sponsor
- Address:
Osteopathie Schule Deutschland/Dresden International University
Jochen Bens
Hamburger Hochstr.22
20359 Hamburg
Germany
- Telephone:
- +49 177 5245575
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
Osteopathie Schule Deutschland
Tobias Schmidt
Weidestr.118c
22083 Hamburg
Germany
- Telephone:
- +494064415690
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
Osteopathie Schule Deutschland
Tobias Schmidt
Weidestr.118c
22083 Hamburg
Germany
- Telephone:
- +494064415690
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
Osteopathie Schule Deutschland
Tobias Schmidt
Weidestr.118c
22083 Hamburg
Germany
- Telephone:
- +494064415690
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
Osteopathie Schule Deutschland
Weidestr.118c
22083 Hamburg
Germany
- Telephone:
- +494064415690
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
Osteopathic Research Institute
Weidestr.118c
22083 Hamburg
Germany
- Telephone:
- +49 40 64415690
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2025-01-31
- Ethics committee number:
- 025-018-B
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2025-03-17
Further identification numbers
- Other WHO Primary Registry or Data Provider ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- No Entry
- Date of the first journal publication of results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry
