The First Affiliated Hospital of Nanjing Medical University
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- nocturnal fluid shift, as determined by change in leg fluid volume
Study Overview
Brief Summary
Fluid retention in the legs due to chronic heart failure (CHF) during the daytime may redistribute to neck when with supine positioning at night. A portion of the shifted fluid accumulates in the neck, and narrows the upper airway, predisposing the patient to obstructive sleep apnea (OSA) and central sleep apnea (CSA). However, the mechanism of overnight fluid shift on OSA and CSA remains unclear. The investigators pre-experiment demonstrated there may be a different mechanism of overnight fluid shift on OSA and CSA. The accumulation of water content in neck soft tissue increases neck circumference and leads to pharyngeal resistance, upper airway collapse and causes OSA. The effect of nocturnal fluid shift on CSA may be because of increasing of chemosensitivity (fluctuation of PaCO2), circulation delay and hemodynamic disordered. This study is aimed to explore the different mechanism of overnight fluid shift on OSA and CSA by comparing the changes of upper airway (inside diameter, water content, and pharyngeal resistance), PaCO2, circulation delay (lung-to-finger circulation time) and hemodynamic (loop gain).
Detailed Description
Methods:
Between June 2015 and December 2017, 180 patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease (in Cardiology Department and Cardiothoracic Surgery Department of the First Affiliated Hospital of Nanjing Medical University), were screened for sleep apnea by polysomnography (PSG). Of them, 20 obstructive sleep apnea (OSA) and 20 central sleep apnea (CSA) were enrolled. Clinical evaluations including NYHA class, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test (6MWT) were recorded.
The fluid index, head and neck CT and pharyngeal resistance were tested at 20:00. Then a full night PSG and percutaneous PaCO2 were performed. The fluid index, head and neck CT and pharyngeal resistance were repeated at 6:00 after PSG.
The volume of fluid shift from legs to head and neck,inside diameter of the upper airway, and water content of neck soft tissue were calculated. The lung-to-finger circulation time and loop gain were measured.
- Mechanism of overnight fluid shift on OSA:
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease
- •aged between 18 to 70 years
- •with symptomatic stable heart failure, New York Heart Association (NYHA) class >= II despite optimal drug therapy
- •patients combined with sleep apnea (apnea-hypopnea index >=10/h) according to the results of polysomnograph.
Exclusion Criteria
- •history of stroke or clinical signs of peripheral or central nervous system disorders
- •chronic obstructive pulmonary disease or history of asthma
- •enrolment in another clinical study
Outcomes
Primary Outcomes
nocturnal fluid shift, as determined by change in leg fluid volume
Time Frame: up to 24 months
Nocturnal fluid shift was measured for 40 enrolled participants.
pharyngeal resistance,as the change from baseline in pharyngeal air-flow resistance
Time Frame: up to 24 months
Pharyngeal resistance was measured for 40 enrolled participants.
Lung to Finger Circulation Time
Time Frame: up to 24 months
Lung to Finger Circulation Time was measured for 40 enrolled participants.
Loop Gain
Time Frame: up to 24 months
Loop Gain was measured for 40 enrolled participants
apnea-hypopnea index, as the severity of sleep apnea.
Time Frame: up to 24 months
Apnea-hypopnea index was measured for 40 enrolled participants.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ning Ding
Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University
Nanjing Medical University