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Sleep Apnea, ObstructiveNCT03267667

Effect of OSA on RV Heamodynamics and Function

An observational study of Sleep Apnea, Obstructive, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Correlation of severity of obstructive sleep apnea and function of the right ventricle by means of 2D echocardiography and cardiac MRI Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
2D Echocardiography and cardiac MRI
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Jan 2019to 1 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study will include 90 patients who are diagnosed as obstructive sleep apnea by sleep study and 10 healthy volunteers

Who may be able to join

  • Subjects diagnosed as OSA with age range from 18 to 70 years
  • Glomerular filtration rate (MDRD formula-based) > 60 ml/min
  • Arterial hypertension diagnosed according to the European Society of Hypertension 2013 Guidelines.

Who cannot join

  • Mental illness
  • Acute and chronic inflammation
  • Heart failure III or IV grade
  • Chronic administration of drugs with confirmed nephrotoxicity and/or sympathicomimetics
  • Obstructive and restrictive pulmonary diseases which may deteriorate the function of the respiratory system

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut university

    Asyut, 71515

Other trials in Egypt

About this study

Official title: Effect of Obstructive Sleep Apnea on Right Ventricle Heamodynamics and Function

Correlation of severity of obstructive sleep apnea and function of the right ventricle by means of 2D echocardiography and cardiac MRI

Read the detailed description

Obstructive sleep apnea (OSA) is a frequently under diagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. OSA is a well established risk factor for systemic hypertension , myocardial infarction or stroke.

Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive collapse of the upper airway during sleep .The obstructive apneic event is associated with considerable breathing efforts against a totally or partially occluded upper airway, and apnea is terminated by an arousal and heavy snoring as airflow is restored. Severity of OSAS is described according to total number of apneas and hyperpneas per hour of sleep, which is named as the apnea-hypopnea index (AHI).

Cardiovascular disturbances are the most serious complications of OSAS. These complications include heart failure, acute myocardial infarction, nocturnal arrhythmias, stroke, systemic and pulmonary hypertension. All these cardiovascular complications increase morbidity and mortality of OSAS.

Currently, sleep apnea is accepted as one of the identifiable causes of hypertension. Also, OSAS is closely associated with obesity and ageing.

There is conclusive evidence that OSAS influences right heart function (the pathophysiological consequences of sleep apnea-hypopnea might result in an imbalance in myocardial oxygen delivery/consumption ratio, activation of sympathetic and other neurohormonal systems, and increased right and left ventricular after load )

Being tested
2D Echocardiography and cardiac MRI
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2D Echocardiography and cardiac MRIDiagnostic test

    imaging of right ventricle by both modalities to assess right ventricle function accurately

Study groups in NCT03267667
Study groupRoleWhat they receive
obstructive sleep apnea patientsnumber of 90 patients will be investigated by 2D echocardiography and cardiac MRI to determine the right ventricle function
Receives: Diagnostic Test: 2D Echocardiography and cardiac MRI
healthy volunteersnumber of 10 subjects will be investigated by 2D echocardiography and cardiac MRI to determine right ventricular function in healthy persons have risk factors other than cardiac or lung diseases
Receives: Diagnostic Test: 2D Echocardiography and cardiac MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The RV function in subjects with OSA compared with healthy persons

    Assessment of RV function by cardiac MRI in OSA patients and healthy volunteers

    Measured: 1 year

Secondary outcomes (1)

  1. Early detection of any impairment in cardiac global function in the participants before causing symptoms.

    Cardiac MRI help to detect early cardiac dysfunction before symptoms appear which causes. Early detection equal early management which will improve the cardiac prognosis

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2020
  4. Study completion1 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03267667
Sponsor's protocol ID
17100300
Status last verified
Apr 2021
First submitted
25 Aug 2017
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.

    PubMed 10770144

  • Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.

    PubMed 10805822

  • Hung J, Whitford EG, Parsons RW, Hillman DR. Association of sleep apnoea with myocardial infarction in men. Lancet. 1990 Aug 4;336(8710):261-4. doi: 10.1016/0140-6736(90)91799-g.

    PubMed 1973968

  • Palomaki H, Partinen M, Erkinjuntti T, Kaste M. Snoring, sleep apnea syndrome, and stroke. Neurology. 1992 Jul;42(7 Suppl 6):75-81; discussion 82.

    PubMed 1630643

  • Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. doi: 10.1146/annurev.me.27.020176.002341. No abstract available.

    PubMed 180875

  • Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. doi: 10.1016/s0735-1097(03)00184-0.

    PubMed 12742277

  • Malone S, Liu PP, Holloway R, Rutherford R, Xie A, Bradley TD. Obstructive sleep apnoea in patients with dilated cardiomyopathy: effects of continuous positive airway pressure. Lancet. 1991 Dec 14;338(8781):1480-4. doi: 10.1016/0140-6736(91)92299-h.

    PubMed 1683918

  • Guilleminault C, Connolly SJ, Winkle RA. Cardiac arrhythmia and conduction disturbances during sleep in 400 patients with sleep apnea syndrome. Am J Cardiol. 1983 Sep 1;52(5):490-4. doi: 10.1016/0002-9149(83)90013-9.

    PubMed 6193700

  • Weitzenblum E, Krieger J, Apprill M, Vallee E, Ehrhart M, Ratomaharo J, Oswald M, Kurtz D. Daytime pulmonary hypertension in patients with obstructive sleep apnea syndrome. Am Rev Respir Dis. 1988 Aug;138(2):345-9. doi: 10.1164/ajrccm/138.2.345.

    PubMed 3143285

  • Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

    PubMed 12748199

  • Levinson PD, McGarvey ST, Carlisle CC, Eveloff SE, Herbert PN, Millman RP. Adiposity and cardiovascular risk factors in men with obstructive sleep apnea. Chest. 1993 May;103(5):1336-42. doi: 10.1378/chest.103.5.1336.

    PubMed 8486007

  • Ancoli-Israel S, Coy T. Are breathing disturbances in elderly equivalent to sleep apnea syndrome? Sleep. 1994 Feb;17(1):77-83. doi: 10.1093/sleep/17.1.77. No abstract available.

    PubMed 8191206

  • Javaheri S. Central sleep apnea in congestive heart failure: prevalence, mechanisms, impact, and therapeutic options. Semin Respir Crit Care Med. 2005 Feb;26(1):44-55. doi: 10.1055/s-2005-864206.

    PubMed 16052417

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Apnea, Obstructive, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The RV function in subjects with OSA compared with healthy persons (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03267667, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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