Loop Gain in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement
The Role and Mechanisms of Loop Gain and Associated Parameters in the Reversion of OSA Treated by Either CPAP or Cardiac Valve Replacement
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
January 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 10, 2021
March 1, 2021
3.4 years
February 7, 2019
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
changes of apnea-hypopnea index
Changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
14 days
changes of lowest SPO2
Changes of lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients.
14 days
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.
7 days
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.
14 days
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.
14 days
Secondary Outcomes (4)
duration of operation
12 hours
duration of cardiopulmonary bypass
12 hours
duration of ICU stays
14 days
duration of mechanical ventilation
14 days
Study Arms (2)
continuous positive airway pressure
EXPERIMENTALThe CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively.
non-continuous positive airway pressure
NO INTERVENTIONThe non-CPAP treatment group received baseline medicine treatment without CPAP treatment.
Interventions
The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Related Publications (2)
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.
PMID: 24938583BACKGROUNDDing 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.
PMID: 27448416BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hong Wang, Ph D
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 15, 2019
Study Start
January 31, 2020
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
March 10, 2021
Record last verified: 2021-03