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

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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