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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulmonary Arterial Denervation
Sham procedure
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham procedure

Pulmonary Arterial Denervation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2016
Last Updated
July 21, 2020
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02687477
Brief Title
PADN to Treat Severe Obstructive Sleep Apnea
Acronym
PADN-OSA
Official Title
Pulmonary Artery Denervation to Treat Severe Obstructive Sleep Apnea: a Single-center, Prospective, First-in-man Study（PADN-OSA）
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients meeting the criteria for admission
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 21, 2020 (Actual)
Study Completion Date
July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
Patients in the sham group will take sham procedure like PADN.
Arm Title
Pulmonary Arterial Denervation
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Arterial Denervation
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Sham procedure
Intervention Description
patient in the sham group will receive sham procedure
Primary Outcome Measure Information:
Title
the change from baseline to month 6 in apnea-hypopnea index
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
the absolute change in Epworth Sleepiness Scale from baseline to follow-up
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
the change in obstruction of the upper airway by MRI scan
Time Frame
Baseline and 6 months
Title
the change in interleukin-6 (IL-6) at 6-month follow-up
Time Frame
Baseline and 6 months
Title
the change in C-reactive protein at 6-month follow-up
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

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PADN to Treat Severe Obstructive Sleep Apnea

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