Sleep ApneaNCT00456287
Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome
A study testing CPAP (Continuous Positive Airway Pressure) in people with Sleep Apnea and Cardiovascular Diseases, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Sleep Apnea, Cardiovascular Diseases
- What is being tested?
- CPAP (Continuous Positive Airway Pressure)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2007to not given
- Phase
- Interventional
- 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 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Apnea-Hypopnea Index > 15
Who cannot join
- Presence of any chronic disease
- Presence of cardiovascular disease
- Refusal to sign informed consent
- Drug addiction and/or alcoholism
- Any medication two weeks before
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: Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events
The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched.
Read the detailed description
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have higher risk of cardiovascular mortality during the night.
Respiratory alterations (hypoxia, hypoxia- reoxygenation) that these patients suffer during the sleep may induce modifications in platelet function, clotting-fibrinolysis factors and endothelial function, that may accelerate cardiovascular events during the night
DESIGN: Prospective and controlled study
METHODS: 20 SAHS patients and 20 controls will be studied. The study includes:
- medical history; b) anthropometric variables (weight, height, body mass index, waist-hip ratio); c) sleepiness tested by Epworth scale; d) conventional polysomnography (PSG); e) testing every 4 hours for a 24 hours period: clotting-fibrinolysis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); platelet activation markers (CD62, CD63 and GPIIb/IIIa) and endothelial dysfunction markers (endothelins, nitrites/nitrates and asymmetrical dimethyl-arginine); f) basic biochemical profile and hemogram. Patients will be revaluated after 6 months of CPAP treatment.
- Conditions
- Sleep Apnea, Cardiovascular Diseases
- Being tested
- CPAP (Continuous Positive Airway Pressure)
- Keywords
- Sleep Apnea, Clotting- fibrinolysis patterns, Platelet function markers, Endothelial dysfunction
- Medical subject headings
- Sleep Apnea Syndromes, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP (Continuous Positive Airway Pressure)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
Secondary outcomes (1)
CPAP (Continuous Positive Airway Pressure) effect on studied variables
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Fundacion Caubet-Cimera Islas Baleares
- Investigators
- Antonia Barceló, MD, Principal investigator, Hospital Universitario Son Dureta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456287
- Sponsor's protocol ID
- PR-109
- Status last verified
- Apr 2007
- First submitted
- 2 Apr 2007
- Last updated
- 4 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events
- ClinicalTrials.gov ID
- NCT00456287
- Acronym / sponsor ID
- PR-109
- Conditions
- Sleep Apnea, Cardiovascular Diseases
- Keywords
- Sleep Apnea, Clotting- fibrinolysis patterns, Platelet function markers, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Fundacion Caubet-Cimera Islas Baleares
- Study start
- Feb 2007
- First posted
- 4 Apr 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.
The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched.
Detailed description
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have higher risk of cardiovascular mortality during the night.
Respiratory alterations (hypoxia, hypoxia- reoxygenation) that these patients suffer during the sleep may induce modifications in platelet function, clotting-fibrinolysis factors and endothelial function, that may accelerate cardiovascular events during the night
DESIGN: Prospective and controlled study
METHODS: 20 SAHS patients and 20 controls will be studied. The study includes:
- medical history; b) anthropometric variables (weight, height, body mass index, waist-hip ratio); c) sleepiness tested by Epworth scale; d) conventional polysomnography (PSG); e) testing every 4 hours for a 24 hours period: clotting-fibrinolysis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); platelet activation markers (CD62, CD63 and GPIIb/IIIa) and endothelial dysfunction markers (endothelins, nitrites/nitrates and asymmetrical dimethyl-arginine); f) basic biochemical profile and hemogram. Patients will be revaluated after 6 months of CPAP treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Apnea-Hypopnea Index > 15
Key exclusion criteria (5 listed)
- Presence of any chronic disease
- Presence of cardiovascular disease
- Refusal to sign informed consent
- Drug addiction and/or alcoholism
- Any medication two weeks before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP (Continuous Positive Airway Pressure) | Device | – |
Primary outcome
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
1 secondary outcome
CPAP (Continuous Positive Airway Pressure) effect on studied variables
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
Antonia Barceló, MD principal investigator
Hospital Universitario Son Dureta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP (Continuous Positive Airway Pressure) in people with Sleep Apnea and Cardiovascular Diseases, 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 1 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 4 Apr 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 Antonia Barceló, MD (34 971 175112, abarcelo@hsd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction. It is what the study was designed to measure, not a finding.
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 4 Apr 2007.