Sleep Apnea, ObstructiveNCT00640536
Right Ventricular Function in Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the structural and functional cardiac alterations in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension and their correlation to the severity of OSA. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2006to Jun 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tertiary care clinic, obstructive sleep apnea patients
Who may be able to join
- For OSA patients (group1)
- Apnea Hypopnea Index equal or more than 15
- Epworth sleepiness scale equal or more than 10
- No previous treatment for OSA
Who cannot join
- Age < 18 years
- Known hypertension, or 24-hour mean blood pressure of 135 and/or 85 mmHg or more
- Mean pulmonary artery pressure > 25 mmHg
- Diabetes mellitus
- Left ventricular ejection fraction < 60%
- Moderate to severe valvular disease
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- Cardiomyopathy
- Renal failure
- Coronary artery disease
- Obstructive or restrictive lung disease demonstrated on pulmonary function test
- Connective-tissue or chronic thromboembolic disease
- Pericardial disease
- Cancer and/or other important comorbidities with an expected survival < 2 years
- Suboptimal echocardiographic images for measurements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Florence Nightingale Hospital
Istanbul, Caglayan, 34381
About this study
Official title: The Evaluation of Subclinical Right Ventricular Dysfunction in Obstructive Sleep Apnea Patients Without Systemic and Pulmonary Arterial Hypertension Using Velocity Vector Imaging
The purpose of this study is to determine the structural and functional cardiac alterations in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension and their correlation to the severity of OSA.
Read the detailed description
Many risk factors for OSA, such as male gender, obesity, and increasing age are the same as for cardiovascular diseases. This fact makes it more difficult to establish a causal relationship between OSA and cardiovascular diseases. The relationship between OSA and right ventricular (RV) function is controversial. RV dysfunction may be a result of chronic intermittent hypoxia and hypercapnia during apneic episodes. It may also occur secondary to left ventricular dysfunction as a result of increased afterload and sympathetic activity which causes secondary hypertension. As systemic hypertension is one of the most accompanying and contributing factors in OSA along with obesity, we tried to compare the effects of newly diagnosed OSA on RV function with an age and body mass index- matched control group.
- Conditions
- Sleep Apnea, Obstructive
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Newly diagnosed obstructive sleep apnea patients without systemic and pulmonary arterial hypertension | |
| 2 | Age, sex and and body mass index-matched matched healthy subjects |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florence Nightingale Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Saide Aytekin, Principal investigator, T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640536
- Sponsor's protocol ID
- AT-1974/1
- Status last verified
- Nov 2008
- First submitted
- 17 Mar 2008
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Otto ME, Belohlavek M, Romero-Corral A, Gami AS, Gilman G, Svatikova A, Amin RS, Lopez-Jimenez F, Khandheria BK, Somers VK. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007 May 1;99(9):1298-302. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.
PubMed 17478161Okuda N, Ito T, Emura N, Suwa M, Hayashi T, Yoneda H, Kitaura Y. Depressed myocardial contractile reserve in patients with obstructive sleep apnea assessed by tissue Doppler imaging with dobutamine stress echocardiography. Chest. 2007 Apr;131(4):1082-9. doi: 10.1378/chest.06-2444.
PubMed 17426213Tavil Y, Kanbay A, Sen N, Ulukavak Ciftci T, Abaci A, Yalcin MR, Kokturk O, Cengel A. The relationship between aortic stiffness and cardiac function in patients with obstructive sleep apnea, independently from systemic hypertension. J Am Soc Echocardiogr. 2007 Apr;20(4):366-72. doi: 10.1016/j.echo.2006.09.005.
PubMed 17400115Tavil Y, Kanbay A, Sen N, Ciftci TU, Abaci A, Yalcin MR, Kokturk O, Cengel A. Comparison of right ventricular functions by tissue Doppler imaging in patients with obstructive sleep apnea syndrome with or without hypertension. Int J Cardiovasc Imaging. 2007 Aug;23(4):469-77. doi: 10.1007/s10554-006-9168-6. Epub 2006 Oct 20.
PubMed 17054014
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Subclinical Right Ventricular Dysfunction in Obstructive Sleep Apnea Patients Without Systemic and Pulmonary Arterial Hypertension Using Velocity Vector Imaging
- ClinicalTrials.gov ID
- NCT00640536
- Acronym / sponsor ID
- AT-1974/1
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Florence Nightingale Hospital, IstanbulUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the structural and functional cardiac alterations in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension and their correlation to the severity of OSA.
Detailed description
Many risk factors for OSA, such as male gender, obesity, and increasing age are the same as for cardiovascular diseases. This fact makes it more difficult to establish a causal relationship between OSA and cardiovascular diseases. The relationship between OSA and right ventricular (RV) function is controversial. RV dysfunction may be a result of chronic intermittent hypoxia and hypercapnia during apneic episodes. It may also occur secondary to left ventricular dysfunction as a result of increased afterload and sympathetic activity which causes secondary hypertension. As systemic hypertension is one of the most accompanying and contributing factors in OSA along with obesity, we tried to compare the effects of newly diagnosed OSA on RV function with an age and body mass index- matched control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Newly diagnosed obstructive sleep apnea patients without systemic and pulmonary arterial hypertension |
| 2 | – | –Age, sex and and body mass index-matched matched healthy subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic, obstructive sleep apnea patients
Key inclusion criteria (4 listed)
- For OSA patients (group1)
- Apnea Hypopnea Index equal or more than 15
- Epworth sleepiness scale equal or more than 10
- No previous treatment for OSA
Key exclusion criteria (14 listed)
- Age < 18 years
- Known hypertension, or 24-hour mean blood pressure of 135 and/or 85 mmHg or more
- Mean pulmonary artery pressure > 25 mmHg
- Diabetes mellitus
- Left ventricular ejection fraction < 60%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2008.
- Background: PubMed 17478161Otto ME, Belohlavek M, Romero-Corral A, Gami AS, Gilman G, Svatikova A, Amin RS, Lopez-Jimenez F, Khandheria BK, Somers VK. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007 May 1;99(9):1298-302. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.
- Background: PubMed 17426213Okuda N, Ito T, Emura N, Suwa M, Hayashi T, Yoneda H, Kitaura Y. Depressed myocardial contractile reserve in patients with obstructive sleep apnea assessed by tissue Doppler imaging with dobutamine stress echocardiography. Chest. 2007 Apr;131(4):1082-9. doi: 10.1378/chest.06-2444.
- Background: PubMed 17400115Tavil Y, Kanbay A, Sen N, Ulukavak Ciftci T, Abaci A, Yalcin MR, Kokturk O, Cengel A. The relationship between aortic stiffness and cardiac function in patients with obstructive sleep apnea, independently from systemic hypertension. J Am Soc Echocardiogr. 2007 Apr;20(4):366-72. doi: 10.1016/j.echo.2006.09.005.
- Background: PubMed 17054014Tavil Y, Kanbay A, Sen N, Ciftci TU, Abaci A, Yalcin MR, Kokturk O, Cengel A. Comparison of right ventricular functions by tissue Doppler imaging in patients with obstructive sleep apnea syndrome with or without hypertension. Int J Cardiovasc Imaging. 2007 Aug;23(4):469-77. doi: 10.1007/s10554-006-9168-6. Epub 2006 Oct 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saide Aytekin principal investigator
T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 4 inclusion and 14 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 1 Dec 2008. 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 Turkey (Türkiye). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640536, which also lists 4 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 1 Dec 2008.