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NCT Number: NCT02349997

Fluid Shift on Obstructive and Central Sleep Apnea

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).

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Key information

Conditions

Apnea (Central and Obstructive) Apnea Cheyne-Stokes Respiration Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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:

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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

This is an observational study and no intervention applied.

Primary outcomes

  1. 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.

  2. 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.

  3. Lung to Finger Circulation Time

    Time frame: up to 24 months

    Lung to Finger Circulation Time was measured for 40 enrolled participants.

  4. Loop Gain

    Time frame: up to 24 months

    Loop Gain was measured for 40 enrolled participants

  5. apnea-hypopnea index, as the severity of sleep apnea.

    Time frame: up to 24 months

    Apnea-hypopnea index was measured for 40 enrolled participants.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

The First Affiliated Hospital of Nanjing Medical University

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 29, 2015
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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