PADN to Treat Severe Obstructive Sleep Apnea

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Procedure: Sham procedure; Procedure: Pulmonary Arterial Denervation

• Registration Number: NCT02687477
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-22
• Status Verified: 2020-07
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure	Sham procedure	Patients in the sham group will take sham procedure like PADN.
Pulmonary Arterial Denervation	Pulmonary 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.

Primary Outcome Measures

Name	Time	Method
the change from baseline to month 6 in apnea-hypopnea index	Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
the absolute change in Epworth Sleepiness Scale from baseline to follow-up	Baseline and 6 months

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China