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Loop Gain in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement

Primary Purpose

Obstructive Sleep Apnea of Adult, Heart Valve Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
continuous positive airway pressure
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea of Adult focused on measuring Obstructive Sleep Apnea, heart valve replacement, CPAP treatment, loop gain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged 18-75 years.
  2. Patients with heart valve disease.
  3. Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h).
  4. Received cardiac valve replacement surgery.
  5. The enrolled patients having received patients' informed consent.

Exclusion Criteria:

  1. History of stroke or clinical signs of peripheral or central nervous system disorders.
  2. History of chronic obstructive pulmonary disease or asthma.
  3. Enrolment in another clinical study.

Sites / Locations

  • the First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

continuous positive airway pressure

non-continuous positive airway pressure

Arm Description

The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively.

The non-CPAP treatment group received baseline medicine treatment without CPAP treatment.

Outcomes

Primary Outcome Measures

changes of apnea-hypopnea index
Changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
changes of lowest SPO2
Changes of lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients.
comparison of loop gain
Loop gain pre- and post-operative was compared between CPAP and non-CPAP patients. Loop gain pre- and post-CPAP treatment were compared in CPAP group.
arousal threshold
Arousal threshold pre- and post-operative was compared between CPAP and non-CPAP patients. Arousal threshold pre- and post-CPAP treatment were compared in CPAP group.
upper airway gain
Upper airway gain pre- and post-operative was compared between CPAP and non-CPAP patients. Upper airway gain pre- and post-CPAP treatment were compared in CPAP group.

Secondary Outcome Measures

duration of operation
Duration of operation was compared between CPAP and non-CPAP patients.
duration of cardiopulmonary bypass
Duration of cardiopulmonary bypass was compared between CPAP and non-CPAP patients.
duration of ICU stays
Duration of ICU stays were compared between CPAP and non-CPAP patients.
duration of mechanical ventilation
Postoperative duration of mechanical ventilation was compared between CPAP and non-CPAP patients.

Full Information

First Posted
February 7, 2019
Last Updated
March 8, 2021
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03839654
Brief Title
Loop Gain in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement
Official Title
The Role and Mechanisms of Loop Gain and Associated Parameters in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sleep apnea including obstructive sleep apnea (OSA) and central sleep apnea (CSA), are common in patients with cardiovascular disease. The prevalence of OSA is 2%-4% in general population and 16%-47% in surgical-heart failure patients. The previous studies found that the sleep apnea types shifted from OSA to CSA after continuous positive airway pressure (CPAP) treatment or from CSA to OSA after heart surgery (cardiac valve replacement/ repair or heart transplantation) without the mechanism illuminated clearly. The recent studies found that the loop gain (LG) could predict the effect of upper airway surgery and CPAP treatment on the reversion of OSA. However, in patients with valvular heart disease, whether LG and related parameters can predict the therapeutic efficacy of CPAP or cardiac valve replacement is not expounded clearly. The investigators' previous study found that there were different outcomes of sleep apnea after cardiac valve replacement: elimination or consistent. But the corresponding non-anatomic mechanisms was not clear. The investigators' preliminary experiment showed that the LG and related parameters were not improved while OSA improved by CPAP treatment; however, the recovery of OSA after cardiac valve replacement was closed related to the improvement of LG and related parameters. The investigators speculated that, 1. LG and related parameters could predict OSA outcome of CPAP treatment or cardiac valve replacement. 2. non-anatomic mechanisms including LG and associated parameters, contributed to CPAP treatment and cardiac valve replacement were different. In this study, the investigators aimed to explore the relationship between LG and, outcomes of OSA and the regarding non-anatomic mechanisms in patient with heart valve disease.
Detailed Description
Between January 31, 2020 and June 30, 2023, 300 patients with valvular heart disease waiting for cardiac valve replacement in Department of Cardiovascular Surgery were screened for obstructive sleep apnea (OSA) by full-night polysomnography. Of them, 40 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (20:20). The CPAP treatment group received both baseline medicine and CPAP treatment. The full-night CPAP treatment was conducted from 21:00 pm to 6:00 am for 7 days preoperatively. The non-CPAP treatment group received baseline medicine treatment. LG and related parameters were collected at the first day of treatment in non-CPAP group and both first and last day of treatment in CPAP group. Sleep parameters including apnea-hypopnea index (AHI), mean and lowest SPO2, and clinical evaluations including New York Heart Association (NYHA) classes, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test were recorded. Operation related parameters (duration of operation, duration of cardiopulmonary bypass and bleeding volume) were recorded. Postoperative adverse events such as duration of ICU stay, postoperative duration of mechanical ventilation, pacemaker use, complicated infection and reintubations were recorded. A full-night polysomnography as well as LG and related parameters were re-examined before discharge from hospital. The changes of AHIs, mean and lowest SPO2, LG and related parameters between pre- and post-operative polysomnography parameters were calculated. The correlation between changes of polysomnography and LG parameters pre- and post-CPAP in CPAP group were analyzed. The correlation between changes of polysomnography and LG parameters pre- and post-operative in both CPAP and non-CPAP group were analyzed. The differences of polysomnography and LG parameters, and post-operative adverse events between CPAP and non-CPAP treatment group were analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult, Heart Valve Diseases
Keywords
Obstructive Sleep Apnea, heart valve replacement, CPAP treatment, loop gain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 300 patients with rheumatic valvular heart disease waiting for cardiac valve replacement were screened for obstructive sleep apnea (OSA). Of them, 40 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (20:20 patients). The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline medicine treatment.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
continuous positive airway pressure
Arm Type
Experimental
Arm Description
The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively.
Arm Title
non-continuous positive airway pressure
Arm Type
No Intervention
Arm Description
The non-CPAP treatment group received baseline medicine treatment without CPAP treatment.
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure
Intervention Description
The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively.
Primary Outcome Measure Information:
Title
changes of apnea-hypopnea index
Description
Changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
Time Frame
14 days
Title
changes of lowest SPO2
Description
Changes of lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients.
Time Frame
14 days
Title
comparison of loop gain
Description
Loop gain pre- and post-operative was compared between CPAP and non-CPAP patients. Loop gain pre- and post-CPAP treatment were compared in CPAP group.
Time Frame
7 days
Title
arousal threshold
Description
Arousal threshold pre- and post-operative was compared between CPAP and non-CPAP patients. Arousal threshold pre- and post-CPAP treatment were compared in CPAP group.
Time Frame
14 days
Title
upper airway gain
Description
Upper airway gain pre- and post-operative was compared between CPAP and non-CPAP patients. Upper airway gain pre- and post-CPAP treatment were compared in CPAP group.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
duration of operation
Description
Duration of operation was compared between CPAP and non-CPAP patients.
Time Frame
12 hours
Title
duration of cardiopulmonary bypass
Description
Duration of cardiopulmonary bypass was compared between CPAP and non-CPAP patients.
Time Frame
12 hours
Title
duration of ICU stays
Description
Duration of ICU stays were compared between CPAP and non-CPAP patients.
Time Frame
14 days
Title
duration of mechanical ventilation
Description
Postoperative duration of mechanical ventilation was compared between CPAP and non-CPAP patients.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-75 years. Patients with heart valve disease. Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h). Received cardiac valve replacement surgery. The enrolled patients having received patients' informed consent. Exclusion Criteria: History of stroke or clinical signs of peripheral or central nervous system disorders. History of chronic obstructive pulmonary disease or asthma. Enrolment in another clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Wang, Ph D
Phone
8602568306723
Email
drhongwang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Ding, Ph D
Email
dr.ningding@live.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Wang, Ph D
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Wang, Ph D
Phone
25 68306723
Email
drhongwang@163.com
First Name & Middle Initial & Last Name & Degree
Ding Ning, Ph D
Email
dr.ningding@live.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
24938583
Citation
Ding N, Ni BQ, Zhang XL, Zha WJ, Hutchinson SZ, Lin W, Huang M, Zhang SJ, Wang H. Elimination of central sleep apnea by cardiac valve replacement: a continuous follow-up study in patients with rheumatic valvular heart disease. Sleep Med. 2014 Aug;15(8):880-6. doi: 10.1016/j.sleep.2014.02.007. Epub 2014 May 17.
Results Reference
background
PubMed Identifier
27448416
Citation
Ding N, Ni BQ, Wang H, Ding WX, Xue R, Lin W, Kai Z, Zhang SJ, Zhang XL. Obstructive Sleep Apnea Increases the Perioperative Risk of Cardiac Valve Replacement Surgery: A Prospective Single-Center Study. J Clin Sleep Med. 2016 Oct 15;12(10):1331-1337. doi: 10.5664/jcsm.6182.
Results Reference
background

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Loop Gain in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement

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