G47.31
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Individuals = 18 years of age Patients with severe chronic obstructive sleep apnea for whom surgical intervention is indicated. - Surgical intervention with anterior advancement of the upper and lower jaw with additional counter-clockwise rotation - Capacity to consent - Signed informed consent form Inclusion criteria for controls: - Individuals = 18 years of age - No chronic obstructive sleep apnea - Capacity to consent - Signed informed consent form Behavioral guidelines for Expression Clock genes: - No shift work or jet lag within the previous week Examinations - Women in the study were not menstruating at the time of sample collection - Breakfast between 7:00 and 8:00 a.m., lunch between 11:30 a.m. and 1:30 p.m., dinner between 5:30 and 7:30 p.m. - Bedtime before midnight
Exclusion criteria
Exclusion criteria: - Age <18 years - Missing informed consent - Individuals incapable of giving consent/under legal guardianship - Regarding clock genes: Pre-existing conditions: psychiatric disorders, hypersomnia, insomnia, medications affecting sleep (e.g., melatonin or benzodiazepines), pre-existing malignant conditions (These pre-existing conditions affect circadian rhythms and thus the expression of clock genes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of the AHI postoperatively after bimaxillary osteotomy. AHI measurement as part of the postoperative sleep study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life and postoperative stress levels/stress hormones. Improvement of hunger and satiety, cognitive function and brain activity, circadian rhythms, vital signs, and inflammatory markers postoperatively. Measurement through postoperative laboratory and genetic analyses, and fMRI. | — |
Countries
Germany
Contacts
Charité Universitätsmedizin Berlin