Skip to content

Investigation of vegetative, neurological, and genetic parameters in the context of bimaxillary repositioning osteotomy in patients with chronic obstructive sleep apnea (OSAS) – a prospective, monocentric study

Investigation of vegetative, neurological, and genetic parameters in the context of bimaxillary repositioning osteotomy in patients with chronic obstructive sleep apnea (OSAS) – a prospective, monocentric study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038512
Enrollment
40
Registered
2026-01-06
Start date
2026-01-10
Completion date
Unknown
Last updated
2026-01-12

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: Not all of the parameters collected in this study are included in the routine pre- and postoperative diagnostics of patients with chronic obstructive sleep apnea. Discrepancies exist. Routine
For hormone testing, an additional serum tube must be drawn. - For determining clock genes, an additional special EDTA tube with an EDTA stabilizer must be used. - The additional blood tubes can all b

Sponsors

Charité Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Improvement of the AHI postoperatively after bimaxillary osteotomy. AHI measurement as part of the postoperative sleep study.

Secondary

MeasureTime 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

Public ContactSimon Bigus

Charité Universitätsmedizin Berlin

mkg@charite.de030 450555022

Outcome results

None listed

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