Apnea (Central and Obstructive)NCT02349997
Fluid Shift on Obstructive and Central Sleep Apnea
An observational study of Apnea (Central and Obstructive), run by Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Apnea (Central and Obstructive)
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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).
Read the 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: 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.
- Conditions
- Apnea (Central and Obstructive)
- Being tested
- no interventions
- Keywords
- central sleep apnea, Cheyne-Stokes respiration, obstructive sleep apnea, chronic heart failure, fluid shift
- Medical subject headings
- Apnea, Sleep Apnea, Central, Cheyne-Stokes Respiration, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
This is an observational study and no intervention applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
nocturnal fluid shift, as determined by change in leg fluid volume
Nocturnal fluid shift was measured for 40 enrolled participants.
Measured: up to 24 months
pharyngeal resistance,as the change from baseline in pharyngeal air-flow resistance
Pharyngeal resistance was measured for 40 enrolled participants.
Measured: up to 24 months
Lung to Finger Circulation Time
Lung to Finger Circulation Time was measured for 40 enrolled participants.
Measured: up to 24 months
Loop Gain
Loop Gain was measured for 40 enrolled participants
Measured: up to 24 months
apnea-hypopnea index, as the severity of sleep apnea.
Apnea-hypopnea index was measured for 40 enrolled participants.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Apnea (Central and Obstructive)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Ding, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349997
- Sponsor's protocol ID
- 2014-SR-168
- Status last verified
- Feb 2019
- First submitted
- 18 Jan 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20351237Ding 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.
PubMed 25589967Kasai 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.
PubMed 25317087
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Nanjing Medical University
- ClinicalTrials.gov ID
- NCT02349997
- Acronym / sponsor ID
- 2014-SR-168
- Conditions
- Apnea (Central and Obstructive)
- Keywords
- central sleep apnea, Cheyne-Stokes respiration, obstructive sleep apnea, chronic heart failure, fluid shift
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA group | – | Other: no interventionsOf 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. |
| CSA group | – | Other: no interventionsOf 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionsThis is an observational study and no intervention applied. | Other | CSA group, OSA group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 20351237Yumino 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.
- Background: PubMed 25589967Ding 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.
- Background: PubMed 25317087Kasai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea (Central and Obstructive), run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nocturnal fluid shift, as determined by change in leg fluid volume (time frame: up to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349997, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.