Sleep Apnea SyndromesNCT00501358
Sleep Apnea and Tromboembolic Disease
An observational study of Sleep Apnea Syndromes and Venous Thromboembolism, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Apnea Syndromes, Venous Thromboembolism
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Case group:
- Pulmonary embolism diagnosed by CT Pulmonary Angiography.
- Control group:
- randomly selected from among patients in two primary health care centers in Mallorca without tromboembolic disease
Who cannot join
- Refusal to sign informed consent.
- Expected survival less than 12 months
- Long-term oxygen therapy
- Hospital admission in the previous two months.
- Familiar thrombophilia
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, 07014
About this study
Official title: Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism
There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (VTE).
OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and BMI matched control group. Assessment of the association between SAHS and other risk factors for VTE. To compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with SAHS and VTE and those ones without SAHS.
Read the detailed description
DESIGN: Case-control study.
METHODS: 133 SAHS patients and 133 controls will be studied. The study includes:
- medical history; b) anthropometric variables (weight, height, body mass index, Mallampati index); c) sleepiness tested by Epworth scale; d) London Chest Activity of Daily Living Scale; e) conventional polysomnography (PSG); f) testing: clotting-fibrinolisis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); g) d-dimer and thrombin-antithrombin III complex; h) basic biochemical profile and hemograma; i) Pulmonary artery obstruction index.
- Conditions
- Sleep Apnea Syndromes, Venous Thromboembolism
- Keywords
- SLEEP APNEA, venous thromboembolism, COAGULABILITY, COAGULATION FACTORS, HYPOXIA
- Medical subject headings
- Sleep Apnea Syndromes, Venous Thromboembolism, Hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- Other
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Caubet-Cimera Islas Baleares
- Investigators
- Alberto Alonso, MD, Principal investigator, Sociedad Española de Neumología y Cirugía Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501358
- Sponsor's protocol ID
- TEP-SAHS
- Status last verified
- Jul 2007
- First submitted
- 13 Jul 2007
- Last updated
- 16 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT00501358
- Acronym / sponsor ID
- TEP-SAHS
- Conditions
- Sleep Apnea Syndromes, Venous Thromboembolism
- Keywords
- SLEEP APNEA, venous thromboembolism, COAGULABILITY, COAGULATION FACTORS, HYPOXIA
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Fundacion Caubet-Cimera Islas Baleares
- First posted
- 16 Jul 2007 (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.
There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (VTE).
OBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and BMI matched control group. Assessment of the association between SAHS and other risk factors for VTE. To compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with SAHS and VTE and those ones without SAHS.
Detailed description
DESIGN: Case-control study.
METHODS: 133 SAHS patients and 133 controls will be studied. The study includes:
- medical history; b) anthropometric variables (weight, height, body mass index, Mallampati index); c) sleepiness tested by Epworth scale; d) London Chest Activity of Daily Living Scale; e) conventional polysomnography (PSG); f) testing: clotting-fibrinolisis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); g) d-dimer and thrombin-antithrombin III complex; h) basic biochemical profile and hemograma; i) Pulmonary artery obstruction index.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Case group:
- Pulmonary embolism diagnosed by CT Pulmonary Angiography.
- Control group:
- randomly selected from among patients in two primary health care centers in Mallorca without tromboembolic disease
Key exclusion criteria (5 listed)
- Refusal to sign informed consent.
- Expected survival less than 12 months
- Long-term oxygen therapy
- Hospital admission in the previous two months.
- Familiar thrombophilia
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2007.
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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.
Alberto Alonso, MD principal investigator
Sociedad Española de Neumología y Cirugía Torácica
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 Syndromes and Venous Thromboembolism, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 16 Jul 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Alonso, MD (0034971175112, aalonso@hsd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 Jul 2007.