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

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03276611
• Other study ID #: 17100139
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2017
• Last updated: September 6, 2017
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Amr Youssef, MD
• Phone: 01006554042
• Email: amryoussef111[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea, Obstructive

Intervention

Other:
• echocardiograghy
transthoracic echocardiograghy

Locations

Country	Name	City	State
Egypt	Amr Youssef	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of OSA and CPAP therapy on pulmonary artery pressure and right sided hemodynamics	Transthoracic echocardiography to determine right ventricle and right atrium functional parameters and dimensions and pulmonary artery systolic pressure, echocardiography will be planned for evaluation of OSA before initiation of CPAP therapy and after 3 month of CPAP therapy.	Transthoracic echocardiography will be planned for evaluation of OSA patients regularly used CPAP (at least 5hrs/night) before and after 3 month of initiation of CPAP therapy.