Obstructive Sleep Apnea
Conditions
Keywords
OSA, CPAP
Brief summary
The goal of this clinical trial is to assess the effect of CPAP withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. The main question it aims to answer is: • Is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway pressure, CPAP) on endothelial function and baroreflex sensitivity? Participants will stop using their CPAP for 2 weeks and the investigators will assess vascular and autonomic function before and after the withdrawal. Researchers will compare endothelial and autonomic function at baseline and after 2 weeks of withdrawal to see if there are differences. Moreover, they will assess the association between pulse wave amplitude drop profile and effect of CPAP withdrawal.
Interventions
OTHERCPAP withdrawal
2 weeks of CPAP withdrawal
Sponsors
Raphael Heinzer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
one group, before-after design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old * Diagnosed with OSA (AHI ≥15 events/h), confirmed during screening period * Adequately treated with CPAP therapy for ≥6 months * Able to give informed consent as documented by signature
Exclusion criteria
* Professional drivers will be excluded from the study because temporary withdrawal of CPAP may induce drowsiness. * We will also exclude patients with conditions that may affect endothelial and autonomic function: * Known Diabetes * Known heart failure * Known chronic kidney disease * Pregnant or lactating women * Morbid obesity (≥40 kg/m2) * Known Excessive alcohol consumption * Known Dementia (especially dementia with Lewy bodies). (61) * Patients using alpha and beta blockers * Known atrial fibrillation * Inability to follow the procedures of the study due to language problems or psychological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in flow-mediated dilation | Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP | Endothelial function as measured with flow-mediated dilation |
| Change in the slope of baroreflex sensitivity | Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP | Autonomic function as measure with the slope of BRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial stiffness assessed by the pulse transit time | Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP | arterial stiffness measured by the pulse transit time |
| Nocturnal heart rate variability indices (linear and non linear) | baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP | HRV measured on the ECG of polygraphy |
| Change in heart rate response to the cold pressure test | baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP | delta heart rate before and after cold pressure test |
| Hypoxic burden | baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP | hypoxic burden of sleep apnea based on polysomnography |
Countries
Switzerland
Outcome results
None listed