Fluid Shift on Obstructive and Central Sleep Apnea

NCT02349997 | Completed

• 1 other identifier: 2014-SR-168
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Apnea (Central and Obstructive)

Keywords

central sleep apnea; Cheyne-Stokes respiration; obstructive sleep apnea; chronic heart failure; fluid shift

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

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

Interventions

no interventions OTHER

This is an observational study and no intervention applied.

CSA group; OSA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (3)

• 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.

  PMID: 20351237 BACKGROUND

• 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.

  PMID: 25589967 BACKGROUND

• 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.

  PMID: 25317087 BACKGROUND

MeSH Terms

Conditions

Apnea; Sleep Apnea, Central; Cheyne-Stokes Respiration; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: February 1, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

CN (1)