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Muscular characteristics in obstructive sleep apnea – a prospective controlled MRI analysis

Muscular characteristics in obstructive sleep apnea – a prospective controlled MRI analysis - Prospective controlled MRI analysis in OSA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036711
Enrollment
60
Registered
2025-05-05
Start date
2025-07-01
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: Patients with obstructive sleep apnea (OSA-positive group): - Diagnostic polysomnography with additional EMG electrodes - Examination of inclusion and exclusion criteria. - Assignment to the

Sponsors

Universität Marburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - OSA (AHI > 5) and healthy control (AHI < 5) - Signed informed consent - Age 18–99 years - Clinically and anamnestically confirmed sleep bruxism - Clinically and anamnestically unconfirmed sleep bruxism

Exclusion criteria

Exclusion criteria: - Neuropathic pain - Respiratory insufficiency - Analgesic medication with potential impact on muscle or respiratory function - Malignant diseases - Severe psychiatric disorders - History of extensive surgeries in the head, jaw, or facial region (e.g., major trauma, cleft lip and palate surgery) - Cognitive impairments - Other sleep disorders (e.g., REM sleep behavior disorder, insomnia, periodic limb movement disorder [PLMD]) - Use of psychotropic medication - < 4 hours of sleep recorded during polysomnography or polygraphy - History of surgical interventions for OSA treatment - Lack of informed consent regarding incidental findings (see MRI consent form) - Cardiac pacemakers - Implantable defibrillators - Left ventricular assist devices (LVADs) - Cochlear implants - Implanted insulin pumps (external pumps must be removed prior to imaging) - Neurostimulators - Penile prostheses - Bladder pacemakers - Ferromagnetic surgical clips, e.g., post-carotid endarterectomy or neurosurgical procedures - Metallic foreign bodies in critical locations (e.g., eye, brain, intrathoracic or vascular regions) - Vascular stents implanted less than 72 hours prior to imaging - Joint prostheses or metallic implants for bone stabilization if implanted less than 6 weeks prior to imaging (Note: Titanium implants are generally MRI-compatible after 6 weeks) - Recent myocardial infarction or vascular stents implanted less than 72 hours ago - Large tattoos with metal-containing pigments - Metallic transdermal or subdermal implants - Piercings must be able to be removed for the examination

Design outcomes

Primary

MeasureTime frame
Thickness of the masseter muscle

Secondary

MeasureTime frame
- Morphology and position of the hyoid bone - Analyses of thickness, volume, muscle and fat content of other muscles of the masticatory apparatus and pharynx between the OSA-positive and OSA-negative groups as well as sleep bruxists and non-sleep bruxists. - Cortisol level

Countries

Germany

Contacts

Public ContactJanine Sambale

Universität Marburg

sambale@staff.uni-marburg.de+496421-5863220

Outcome results

None listed

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