NCT03276611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 8, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

August 21, 2017

Last Update Submit

September 6, 2017

Conditions

Keywords

Assessmentpulmonaryarteryrightsidedhemodynamicspatientssleepapneasyndromecontionouspositiveairwaypressuretreatment

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

transthoracic echocardiograghy

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients will be evaluated at the sleep lap of chest department of assiut university hospital over 1 year will be enrolled in the study.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amr Youssef

Asyut, 71111, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21628617BACKGROUND
  • 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.

    PMID: 15452478BACKGROUND
  • 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.

    PMID: 18489948BACKGROUND
  • 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.

    PMID: 20124362BACKGROUND

MeSH Terms

Conditions

ApneaSyndrome

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDiseasePathologic Processes

Study Officials

  • Yahia Shabeeb, MBBCH

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamdy ShamsEdeen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 21, 2017

First Posted

September 8, 2017

Study Start

April 1, 2017

Primary Completion

March 31, 2018

Study Completion

December 31, 2018

Last Updated

September 8, 2017

Record last verified: 2017-08

Locations