Assessment of Pulmonary Artery Pressure and Right Sided Hemodynamics in Patients With OSA Before and After CPAP TTT

NCT ID: NCT03276611

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-12-31

Brief Summary

Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an incidence of 5-20% in the middle-aged population in Europe and Northern America . plumonary hypertension is present in 12%-34% of patients with osa.continous positive air way pressureis the main standard treatment ofOSA.Echocardiograghy is the most common non invasive imaging method for assessment the effect on right ventricular function.

Detailed Description

Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an incidence of 5-20% in the middle-aged population in Europe and Northern America . Pathophysiologic consequences of OSA are increased sympathetic activity, hypoxia, hypercapnia, increased left ventricular after-load , acute arterial hypertension, increased diastolic and systolic pressure of the right ventricle, atrial dilation. Recent studies have shown that OSA is an independent risk factor for cardiovascular mortality and morbidity. OSA has a social impact because of fragmentation of sleep leads to increased daytime sleepiness, decreased intellect, behavioral and personality changes, enuresis and sexual dysfunction.

Pulmonary hypertension is present in 12%-34% of patients with Obstructive Sleep Apnea syndrome. When PH occurs as a consequence of OSA however symptoms may not be present because of obesity and alack of physical exertion or symptoms of PH may be overlapped by other cardiovascular abnormalities.

Continuous positive air way pressure therapy is the main standard treatment of OSA works the best in the most people as positive pressure ventilation functions as a pneumatic splint for the collapsing upper air way. Echocardiography is the most common non invasive imaging method for assessment the effect of right ventricular function.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

echocardiograghy

transthoracic echocardiograghy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Moderate and severe OSA and candidates for initiation of CPAP therapy.

Exclusion Criteria

• Significant lung disease ,lfet sided heart failure,end stage malignancy and advanced organ failure.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yahia Shabeeb Fadel Madi

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yahia Shabeeb, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Amr Youssef

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amr Youssef, MD

Role: CONTACT

amryoussef111@yahoo.com

01006554042

Hamdy ShamsEdeen, MD

Role: CONTACT

ashams98@yahoo.com

01065601161

Facility Contacts

Amr Youssef, MD

Role: primary

amryoussef111@yahoo.com

01006554042

Hamdy ShamsEddin, MD

Role: backup

Ashams98@yahoo.com

01065601161

References

Park JG, Ramar K, Olson EJ. Updates on definition, consequences, and management of obstructive sleep apnea. Mayo Clin Proc. 2011 Jun;86(6):549-54; quiz 554-5. doi: 10.4065/mcp.2010.0810.

Reference Type: BACKGROUND

PMID: 21628617 (View on PubMed)

Gottdiener JS, Bednarz J, Devereux R, Gardin J, Klein A, Manning WJ, Morehead A, Kitzman D, Oh J, Quinones M, Schiller NB, Stein JH, Weissman NJ; American Society of Echocardiography. American Society of Echocardiography recommendations for use of echocardiography in clinical trials. J Am Soc Echocardiogr. 2004 Oct;17(10):1086-119. doi: 10.1016/j.echo.2004.07.013. No abstract available.

Reference Type: BACKGROUND

PMID: 15452478 (View on PubMed)

Kim SH, Cho GY, Shin C, Lim HE, Kim YH, Song WH, Shim WJ, Ahn JC. Impact of obstructive sleep apnea on left ventricular diastolic function. Am J Cardiol. 2008 Jun 1;101(11):1663-8. doi: 10.1016/j.amjcard.2008.01.056. Epub 2008 Apr 18.

Reference Type: BACKGROUND

PMID: 18489948 (View on PubMed)

Jurcut R, Giusca S, La Gerche A, Vasile S, Ginghina C, Voigt JU. The echocardiographic assessment of the right ventricle: what to do in 2010? Eur J Echocardiogr. 2010 Mar;11(2):81-96. doi: 10.1093/ejechocard/jep234. Epub 2010 Feb 2.

Reference Type: BACKGROUND

PMID: 20124362 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

17100139

Identifier Type: -

Identifier Source: org_study_id