Obstructive Sleep ApneaNCT00409045
Evaluation of Obstructive Sleep Apnea as a Risk Factor for Pulmonary Embolism
An observational study of Obstructive Sleep Apnea and Pulmonary Embolism, run by Atlantic Health System at 1 site in United States.
Trial summary
we evaluate the presence of OSA in patients that have a computed tomography (CT) of the chest to rule out pulmonary embolism (PE) to determine if OSA constitutes an independent risk factor for PE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Pulmonary Embolism
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Sep 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male and female patients age 18 years and older
Who may be able to join
- male and female patients age 18 years and older with suspected PE
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Memorial Hospital
Morristown, New Jersey, 07962
About this study
we evaluate the presence of OSA in patients that have a computed tomography (CT) of the chest to rule out pulmonary embolism (PE) to determine if OSA constitutes an independent risk factor for PE.
- Conditions
- Obstructive Sleep Apnea, Pulmonary Embolism
- Keywords
- Obstructive Sleep Apnea, Pulmonary Embolism, male and female patients suspected of having a pulmonary embolism.
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Embolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startNov 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Investigators
- Matthew Epstein, MD, Principal investigator, Atlantic Health System - Morristown Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409045
- Sponsor's protocol ID
- R05-08-002
- Other IDs
- Sleep Apnea
- Status last verified
- Oct 2007
- First submitted
- 6 Dec 2006
- Last updated
- 5 Nov 2007
- Results posted
- No
Publications
Epstein MD, Segal LN, Ibrahim SM, Friedman N, Bustami R. Snoring and the risk of obstructive sleep apnea in patients with pulmonary embolism. Sleep. 2010 Aug;33(8):1069-74. doi: 10.1093/sleep/33.8.1069.
PubMed 20815188
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Obstructive Sleep Apnea as a Risk Factor for Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT00409045
- Acronym / sponsor ID
- R05-08-002
- Conditions
- Obstructive Sleep Apnea, Pulmonary Embolism
- Keywords
- Obstructive Sleep Apnea, Pulmonary Embolism, male and female patients suspected of having a pulmonary embolism.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Dec 2006 (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.
we evaluate the presence of OSA in patients that have a computed tomography (CT) of the chest to rule out pulmonary embolism (PE) to determine if OSA constitutes an independent risk factor for PE.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female patients age 18 years and older
Key inclusion criteria (1 listed)
- male and female patients age 18 years and older with suspected PE
Key exclusion criteria (0 listed)
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 5 Nov 2007.
- Derived from this study: PubMed 20815188Epstein MD, Segal LN, Ibrahim SM, Friedman N, Bustami R. Snoring and the risk of obstructive sleep apnea in patients with pulmonary embolism. Sleep. 2010 Aug;33(8):1069-74. doi: 10.1093/sleep/33.8.1069.
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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.
Matthew Epstein, MD principal investigator
Atlantic Health System - Morristown Memorial Hospital
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 Obstructive Sleep Apnea and Pulmonary Embolism, run by Atlantic Health System at 1 site in United States.
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 1 inclusion and 0 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 5 Nov 2007. 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 United States. 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 NCT00409045, which also lists 1 linked publication.
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 5 Nov 2007.