Fluid Shift on Obstructive and Central Sleep Apnea

The First Affiliated Hospital of Nanjing Medical University

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).

Study Overview

• Status: Completed
• Conditions: Apnea (Central and Obstructive)
• Intervention / Treatment: Other: no interventions

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.

1. Mechanism of overnight fluid shift on OSA:

   Fluid shift volume from legs to head and neck,inside diameter of upper airway, water content of neck soft tissue, percutaneous PaCO2, severity of sleep apnea, minimum SP02, lung-to-finger calculation time and loop gain were measured at 22:00 and repeated at 6:00 next morning in patients with OSA.Correlations between changes of fluid shift volume and changes in diameter of upper airway, water content of neck soft tissue, PaCO2, minimum SP02, lung-to-finger calculation time and loop gain were analyzed.

2. Mechanism of overnight fluid shift on CSA:

Fluid shift volume from legs to head and neck,inside diameter of upper airway, water content of neck soft tissue, percutaneous PaCO2, severity of sleep apnea, minimum SP02, lung-to-finger calculation time and loop gain were measured at 22:00 and repeated at 6:00 next morning in patients with CSA.Correlations between changes of fluid shift volume and changes in diameter of upper airway, water content of neck soft tissue, PaCO2, minimum SP02, lung-to-finger calculation time and loop gain were analyzed.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease.

Description

Inclusion Criteria:

1. patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease
2. aged between 18 to 70 years
3. with symptomatic stable heart failure, New York Heart Association (NYHA) class >= II despite optimal drug therapy
4. patients combined with sleep apnea (apnea-hypopnea index >=10/h) according to the results of polysomnograph.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA group; Of the 180 heart failure patients,20 OSA 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.	Other: no interventions; This is an observational study and no intervention applied.
CSA group; Of the 180 heart failure patients,20 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.	Other: no interventions; This is an observational study and no intervention applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nocturnal fluid shift, as determined by change in leg fluid volume	Nocturnal fluid shift was measured for 40 enrolled participants.	up to 24 months
pharyngeal resistance,as the change from baseline in pharyngeal air-flow resistance	Pharyngeal resistance was measured for 40 enrolled participants.	up to 24 months
Lung to Finger Circulation Time	Lung to Finger Circulation Time was measured for 40 enrolled participants.	up to 24 months
Loop Gain	Loop Gain was measured for 40 enrolled participants	up to 24 months
apnea-hypopnea index, as the severity of sleep apnea.	Apnea-hypopnea index was measured for 40 enrolled participants.	up to 24 months

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Publications and helpful links

General Publications

• Yumino D, Redolfi S, Ruttanaumpawan P, Su MC, Smith S, Newton GE, Mak S, Bradley TD. Nocturnal rostral fluid shift: a unifying concept for the pathogenesis of obstructive and central sleep apnea in men with heart failure. Circulation. 2010 Apr 13;121(14):1598-605. doi: 10.1161/CIRCULATIONAHA.109.902452. Epub 2010 Mar 29.
• Kasai T, Motwani SS, Elias RM, Gabriel JM, Taranto Montemurro L, Yanagisawa N, Spiller N, Paul N, Bradley TD. Influence of rostral fluid shift on upper airway size and mucosal water content. J Clin Sleep Med. 2014 Oct 15;10(10):1069-74. doi: 10.5664/jcsm.4102.
• Ding N, Lin W, Zhang XL, Ding WX, Gu B, Ni BQ, Zhang W, Zhang SJ, Wang H. Overnight fluid shifts in subjects with and without obstructive sleep apnea. J Thorac Dis. 2014 Dec;6(12):1736-41. doi: 10.3978/j.issn.2072-1439.2014.11.19.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: January 18, 2015
• First Submitted That Met QC Criteria: January 24, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 9, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; central sleep apnea; chronic heart failure; Cheyne-Stokes respiration; fluid shift
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: 2014-SR-168