Obstructive Sleep Apnea Syndrome
Conditions
Brief summary
This project is focused on the treatment of severe obstructive sleep apnea with pulmonary artery denervation (PADN). Although it has now been proved that continuous positive airway pressure (CPAP) is the primary treatment for obstructive sleep apnea, on the other hand, there is evidence that 25 to 50% of patients can not tolerate CPAP. The investigators previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of pulmonary hypertension. Excessive sympathetic activation play an important role in the occurrence and development of OSA and cause cardiovascular events. It is worth evaluating the feasibility and tolerance of introducing PADN at the severe stage of obstructive sleep apnea. Therefore, the purpose of our study is to evaluate the safety and feasibility of PADN in the treatment of severe OSA.
Interventions
PROCEDUREPulmonary Arterial Denervation
Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.
PROCEDURESham procedure
patient in the sham group will receive sham procedure
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Apnea hypopnea index more than 30, not tolerated or refused continuous positive airway pressure;
Exclusion criteria
* Acute coronary syndrome; * Pregnant; * Expected life less than 12 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change from baseline to month 6 in apnea-hypopnea index | Baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| the absolute change in Epworth Sleepiness Scale from baseline to follow-up | Baseline and 6 months |
Other
| Measure | Time frame |
|---|---|
| the change in obstruction of the upper airway by MRI scan | Baseline and 6 months |
| the change in interleukin-6 (IL-6) at 6-month follow-up | Baseline and 6 months |
| the change in C-reactive protein at 6-month follow-up | Baseline and 6 months |
Countries
China
Outcome results
None listed