ClinicalTrials.gg
Status unknownNCT03276611Updated Sep 8, 2017

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

An observational study in Obstructive Sleep Apnea of Adult, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged Up to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-08.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
Up to 70 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea of Adult

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Keywords

  • Assessment
  • pulmonary
  • artery
  • right
  • sided
  • hemodynamics
  • patients
  • sleep
  • apnea
  • syndrome
  • contionous
  • positive
  • air
  • way
  • pressure
  • treatment
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In context

Apnea

282 studies on the registry are indexed under Apnea; 54 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 78 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Significant lung disease ,lfet sided heart failure,end stage and advanced organ failure.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Otherechocardiograghy

    transthoracic echocardiograghy

06

What researchers measure

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.

    Time frame: 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.

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 21628617 ↗
  • 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. PubMed 15452478 ↗
  • 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. PubMed 18489948 ↗
  • 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. PubMed 20124362 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2017 (actual). Primary completion is estimated for Mar 2018, 11 months after the start.

Of 35 observational studies under Apnea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 38. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2017
First posted
Sep 8, 2017
StartActual
Apr 1, 2017
Primary completionEst.
Mar 31, 2018
CompletionEst.
Dec 31, 2018
Last update
Sep 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03276611
Lead sponsor
Assiut University
Responsible party
Yahia Shabeeb Fadel Madi (principle investigator, Assiut University) — Principal investigator
First posted
Sep 8, 2017
Start date
Apr 1, 2017
Primary completion
Mar 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Sep 8, 2017

Study contacts

Amr Youssef, MD
Contact
amryoussef111@yahoo.com
01006554042
Hamdy ShamsEdeen, MD
Contact
ashams98@yahoo.com
01065601161
Yahia Shabeeb, MBBCH
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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