PADN to Treat Severe Obstructive Sleep Apnea (PADN-OSA)

Nanjing Medical University

Status: Terminated

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Procedure: Pulmonary Arterial Denervation; Procedure: Sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02687477

NFH20160106

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Sham procedure

Sham Comparator group

Description:

Patients in the sham group will take sham procedure like PADN.

Treatment:

Procedure: Sham procedure

Pulmonary Arterial Denervation

Experimental group

Description:

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.

Treatment:

Procedure: Pulmonary Arterial Denervation