PADN to Treat Severe Obstructive Sleep Apnea

Obstructive Sleep Apnea Syndrome Clinical Trial

— PADN-OSA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02687477
• Other study ID #: NFH20160106
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 21, 2020

Study information

• Verified date: July 2020
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 21, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• Sham procedure
patient in the sham group will receive sham procedure

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the change in obstruction of the upper airway by MRI scan		Baseline and 6 months
Other	the change in interleukin-6 (IL-6) at 6-month follow-up		Baseline and 6 months
Other	the change in C-reactive protein at 6-month follow-up		Baseline and 6 months
Primary	the change from baseline to month 6 in apnea-hypopnea index		Baseline and 6 months
Secondary	the absolute change in Epworth Sleepiness Scale from baseline to follow-up		Baseline and 6 months