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

Pulmonary Artery Denervation to Treat Severe Obstructive Sleep Apnea: a Single-center, Prospective, First-in-man Study（PADN-OSA）

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Procedure: Sham procedure; Procedure: Pulmonary Arterial Denervation

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham procedure; Patients in the sham group will take sham procedure like PADN.	Procedure: Sham procedure; patient in the sham group will receive sham procedure
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change from baseline to month 6 in apnea-hypopnea index	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the absolute change in Epworth Sleepiness Scale from baseline to follow-up	Baseline and 6 months

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Shao-Liang Chen, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 21, 2020
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: NFH20160106