MedDataX Logo

Right Ventricular Function in Obstructive Sleep Apnea

NCT ID: NCT00640536

Last Updated: 2008-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the structural and functional cardiac alterations in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension and their correlation to the severity of OSA.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Many risk factors for OSA, such as male gender, obesity, and increasing age are the same as for cardiovascular diseases. This fact makes it more difficult to establish a causal relationship between OSA and cardiovascular diseases. The relationship between OSA and right ventricular (RV) function is controversial. RV dysfunction may be a result of chronic intermittent hypoxia and hypercapnia during apneic episodes. It may also occur secondary to left ventricular dysfunction as a result of increased afterload and sympathetic activity which causes secondary hypertension. As systemic hypertension is one of the most accompanying and contributing factors in OSA along with obesity, we tried to compare the effects of newly diagnosed OSA on RV function with an age and body mass index- matched control group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea, Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Newly diagnosed obstructive sleep apnea patients without systemic and pulmonary arterial hypertension

No interventions assigned to this group

2

Age, sex and and body mass index-matched matched healthy subjects

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

For OSA patients (group1)

* Apnea Hypopnea Index equal or more than 15
* Epworth sleepiness scale equal or more than 10
* No previous treatment for OSA

Exclusion Criteria

* Age \< 18 years
* Known hypertension, or 24-hour mean blood pressure of 135 and/or 85 mmHg or more
* Mean pulmonary artery pressure \> 25 mmHg
* Diabetes mellitus
* Left ventricular ejection fraction \< 60%
* Moderate to severe valvular disease
* Cardiomyopathy
* Renal failure
* Coronary artery disease
* Obstructive or restrictive lung disease demonstrated on pulmonary function test
* Connective-tissue or chronic thromboembolic disease
* Pericardial disease
* Cancer and/or other important comorbidities with an expected survival \< 2 years
* Suboptimal echocardiographic images for measurements
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florence Nightingale Hospital, Istanbul

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

T.C. Istanbul Bilim University; Florence Nightingale Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saide Aytekin

Role: PRINCIPAL_INVESTIGATOR

T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florence Nightingale Hospital

Istanbul, Caglayan, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Otto ME, Belohlavek M, Romero-Corral A, Gami AS, Gilman G, Svatikova A, Amin RS, Lopez-Jimenez F, Khandheria BK, Somers VK. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007 May 1;99(9):1298-302. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.

Reference Type BACKGROUND
PMID: 17478161 (View on PubMed)

Okuda N, Ito T, Emura N, Suwa M, Hayashi T, Yoneda H, Kitaura Y. Depressed myocardial contractile reserve in patients with obstructive sleep apnea assessed by tissue Doppler imaging with dobutamine stress echocardiography. Chest. 2007 Apr;131(4):1082-9. doi: 10.1378/chest.06-2444.

Reference Type BACKGROUND
PMID: 17426213 (View on PubMed)

Tavil Y, Kanbay A, Sen N, Ulukavak Ciftci T, Abaci A, Yalcin MR, Kokturk O, Cengel A. The relationship between aortic stiffness and cardiac function in patients with obstructive sleep apnea, independently from systemic hypertension. J Am Soc Echocardiogr. 2007 Apr;20(4):366-72. doi: 10.1016/j.echo.2006.09.005.

Reference Type BACKGROUND
PMID: 17400115 (View on PubMed)

Tavil Y, Kanbay A, Sen N, Ciftci TU, Abaci A, Yalcin MR, Kokturk O, Cengel A. Comparison of right ventricular functions by tissue Doppler imaging in patients with obstructive sleep apnea syndrome with or without hypertension. Int J Cardiovasc Imaging. 2007 Aug;23(4):469-77. doi: 10.1007/s10554-006-9168-6. Epub 2006 Oct 20.

Reference Type BACKGROUND
PMID: 17054014 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AT-1974/1

Identifier Type: -

Identifier Source: org_study_id