PADN to Treat Severe Obstructive Sleep Apnea

NCT02687477 | Terminated DMC

• 1 other identifier: NFH20160106
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• the change from baseline to month 6 in apnea-hypopnea index

  Baseline and 6 months

Secondary Outcomes (1)

• the absolute change in Epworth Sleepiness Scale from baseline to follow-up

  Baseline and 6 months

Other Outcomes (3)

• 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

Study Arms (2)

Sham procedure

SHAM COMPARATOR

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

Procedure: Sham procedure

Pulmonary Arterial Denervation

EXPERIMENTAL

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

Interventions

Pulmonary Arterial Denervation PROCEDURE

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.

Pulmonary Arterial Denervation

Sham procedure PROCEDURE

patient in the sham group will receive sham procedure

Sham procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apnea hypopnea index more than 30, not tolerated or refused continuous positive airway pressure;

You may not qualify if:

• Acute coronary syndrome;
• Pregnant;
• Expected life less than 12 months;

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Shao-Liang Chen

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

CN (1)