Obstructive Sleep ApneaNCT03513926
Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.
An observational study of Obstructive Sleep Apnea and Hypertension, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
Evaluation of anthropometric, clinical and biological profile in four groups that represents transversely the natural history of Obstructive Sleep Apnea (OSA) and its associated cardiovascular comorbidities: non-OSA, OSA without hypertension, OSA and with hypertension and OSA with a cardiovascular event (CVE). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension, Cardiovascular Diseases
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 338 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Sep 2018
- How long will I take part?
- 6 Months
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Suspected OSA patients attending consecutively to the Sleep Unit of the University Hospital Arnau de Vilanova- Santa María de Lleida are included.
Who may be able to join
- Consecutive patients with suspected OSA that attend to Sleep Unit of Hospital Arnau de Vilanova- Santa Maria de Lleida.
- 18-60 years old
Who cannot join
- Any chronic disease (malignancy, renal insufficiency (glomerular filtration rate <30 ml / min), severe chronic obstructive pulmonary disease, chronic depression and other chronic diseases very limiting),
- Any sleep disorder previously diagnosed: narcolepsy, insomnia, chronic lack of sleep, regular use of hypnotic or sedative drugs and restless leg syndrome
- Any genetic abnormality or disease
- Any medical, social or geographical factors which may endanger patient compliance. (For example, consumption of alcohol (more than 80 g / day in men and 60 g / day in women), disorientation, or a history of default).
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of anthropometric, clinical and biological profile in four groups that represents transversely the natural history of Obstructive Sleep Apnea (OSA) and its associated cardiovascular comorbidities: non-OSA, OSA without hypertension, OSA and with hypertension and OSA with a cardiovascular event (CVE).
Read the detailed description
Aims: The main objective of the study is to determine the risk profile associated with the development of cardiovascular (CV) disease in patients with OSA. To do this, by using genomic analysis tools, transcriptome and the analysis of protein markers are established the following objectives: 1) to determine differences in phenotypic profile (anthropometric, clinical, analytical and biological variables) from different populations: non-hypertensive patient with OSA, OSA hypertensive patient, OSA hypertensive patient who has developed a CV event and healthy subject. These four populations represent transversely the natural history of OSA. In this way the phenotype of the OSA patient and its relationship with risk of developing of CV disease will be defined. 2) To define the changes produced in these profiles after effective treatment with continuous positive airway pressure (CPAP). This approach allows to evaluate the different pathogenic pathways related to CV risk in patients with OSA. 3) To define a predictive model of cardiovascular risk and response to CPAP treatment, in patients with OSA. 4) To phenotype and define the different and segregated clusters of OSA patients whose recognition may improve prognostic predictions and guide therapeutic strategies Methodology: For ethical reasons a longitudinal study cannot be carried out to know history natural the disease (can not leave without treatment patients with OSA long term). We propose a transversal study in which will be include four populations that representing transversally the natural history of OSA (non-OSA individuals, non-hypertensive OSA patients, OSA patients with hypertension and hypertensive OSA patients who have developed a CV event). All the patients will be performed a general analysis, lipid profile and polysomnography. The expression profile of microRNAs associated with cardiovascular risk will be assessed in addition to the gene expression profile associated with arterial hypertension. The measurements are made at baseline and 6 months after effective treatment with CPAP. This methodological approach will contribute in the identification of OSA phenotype which could develop cardiovascular disease.
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- miRNA, Cardiovascular Risk, CPAP, Obstructive Sleep Apnea, Hypertension, Molecular profile
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Also called CPAP
Continuous Positive Airway Pressure
| Study group | Role | What they receive |
|---|---|---|
| Non-OSA group | Patients with out sleep apnea. | |
| OSA group | Patients with OSA, without cardiovascular comorbidities who could be treated with Continuous Positive Airway Pressure Receives: Device: Continuous Positive Airway Pressure | |
| OSA with hypertension group | Patients with OSA, with hypertension who could be treated with Continuous Positive Airway Pressure Receives: Device: Continuous Positive Airway Pressure | |
| OSA with CVE group | Patients with OSA, with a previous ictus or stroke who could be treated with Continuous Positive Airway Pressure Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modeling the cardiovascular (CV) disease risk in patients with obstructive sleep apnea (OSA) through the analysis of the number and specific biomarkers.
Anthropometric, clinical, analytical and biological variables characterization from different populations:non-OSA, OSA without hypertension, OSA with hypertension and OSA with a CV event. The evaluation of these variables will permit the characterization of the profile associated with CV disease in patients with OSA.
Measured: Baseline
Secondary outcomes (2)
Modeling the effect of the treatment with continuous positive airway pressure (CPAP) in patients with OSA with and without cardiovascular disease, through the analysis of the number and specific biomarkers.
Anthropometric, clinical, analytical and biological variables characterization from different populations:non-OSA, OSA without hypertension, OSA with hypertension and OSA with a CV event. The evaluation of these variables changes after CPAP treatment will allow to characterize the effect of this treatment in biomarker related with CV disease
Measured: After 6 months of follow-up
Predictive model of cardiovascular risk
Define a predictive model of cardiovascular risk and response to CPAP treatment, in patients with OSA.
Measured: After 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study startNov 2014
- Primary completionJan 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 338 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbé, MD, Principal investigator, Sociedad Española de Neumología y Cirugía TorácicaManuel Sanchez-de-la-Torre, PhD, Principal investigator, Consorcio Centro de Investigación Biomédica en Red (CIBER)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513926
- Sponsor's protocol ID
- PI14/01266
- Status last verified
- Apr 2019
- First submitted
- 4 May 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.
- ClinicalTrials.gov ID
- NCT03513926
- Acronym / sponsor ID
- PI14/01266
- Keywords
- miRNA, Cardiovascular Risk, CPAP, Obstructive Sleep Apnea, Hypertension, Molecular profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- Nov 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 May 2018 (actual)
- 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.
Evaluation of anthropometric, clinical and biological profile in four groups that represents transversely the natural history of Obstructive Sleep Apnea (OSA) and its associated cardiovascular comorbidities: non-OSA, OSA without hypertension, OSA and with hypertension and OSA with a cardiovascular event (CVE).
Detailed description
Aims: The main objective of the study is to determine the risk profile associated with the development of cardiovascular (CV) disease in patients with OSA. To do this, by using genomic analysis tools, transcriptome and the analysis of protein markers are established the following objectives: 1) to determine differences in phenotypic profile (anthropometric, clinical, analytical and biological variables) from different populations: non-hypertensive patient with OSA, OSA hypertensive patient, OSA hypertensive patient who has developed a CV event and healthy subject. These four populations represent transversely the natural history of OSA. In this way the phenotype of the OSA patient and its relationship with risk of developing of CV disease will be defined. 2) To define the changes produced in these profiles after effective treatment with continuous positive airway pressure (CPAP). This approach allows to evaluate the different pathogenic pathways related to CV risk in patients with OSA. 3) To define a predictive model of cardiovascular risk and response to CPAP treatment, in patients with OSA. 4) To phenotype and define the different and segregated clusters of OSA patients whose recognition may improve prognostic predictions and guide therapeutic strategies Methodology: For ethical reasons a longitudinal study cannot be carried out to know history natural the disease (can not leave without treatment patients with OSA long term). We propose a transversal study in which will be include four populations that representing transversally the natural history of OSA (non-OSA individuals, non-hypertensive OSA patients, OSA patients with hypertension and hypertensive OSA patients who have developed a CV event). All the patients will be performed a general analysis, lipid profile and polysomnography. The expression profile of microRNAs associated with cardiovascular risk will be assessed in addition to the gene expression profile associated with arterial hypertension. The measurements are made at baseline and 6 months after effective treatment with CPAP. This methodological approach will contribute in the identification of OSA phenotype which could develop cardiovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-OSA group | – | –Patients with out sleep apnea. |
| OSA group | – | Device: Continuous Positive Airway PressurePatients with OSA, without cardiovascular comorbidities who could be treated with Continuous Positive Airway Pressure |
| OSA with hypertension group | – | Device: Continuous Positive Airway PressurePatients with OSA, with hypertension who could be treated with Continuous Positive Airway Pressure |
| OSA with CVE group | – | Device: Continuous Positive Airway PressurePatients with OSA, with a previous ictus or stroke who could be treated with Continuous Positive Airway Pressure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Suspected OSA patients attending consecutively to the Sleep Unit of the University Hospital Arnau de Vilanova- Santa María de Lleida are included.
Key inclusion criteria (2 listed)
- Consecutive patients with suspected OSA that attend to Sleep Unit of Hospital Arnau de Vilanova- Santa Maria de Lleida.
- 18-60 years old
Key exclusion criteria (4 listed)
- Any chronic disease (malignancy, renal insufficiency (glomerular filtration rate <30 ml / min), severe chronic obstructive pulmonary disease, chronic depression and other chronic diseases very limiting),
- Any sleep disorder previously diagnosed: narcolepsy, insomnia, chronic lack of sleep, regular use of hypnotic or sedative drugs and restless leg syndrome
- Any genetic abnormality or disease
- Any medical, social or geographical factors which may endanger patient compliance. (For example, consumption of alcohol (more than 80 g / day in men and 60 g / day in women), disorientation, or a history of default).
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 |
|---|---|---|
| Continuous Positive Airway PressureAlso: CPAPContinuous Positive Airway Pressure | Device | OSA group, OSA with CVE group, OSA with hypertension group |
Primary outcome
Modeling the cardiovascular (CV) disease risk in patients with obstructive sleep apnea (OSA) through the analysis of the number and specific biomarkers.
Time frame: Baseline
Anthropometric, clinical, analytical and biological variables characterization from different populations:non-OSA, OSA without hypertension, OSA with hypertension and OSA with a CV event. The evaluation of these variables will permit the characterization of the profile associated with CV disease in patients with OSA.
2 secondary outcomes
Modeling the effect of the treatment with continuous positive airway pressure (CPAP) in patients with OSA with and without cardiovascular disease, through the analysis of the number and specific biomarkers.
Time frame: After 6 months of follow-up
Predictive model of cardiovascular risk
Time frame: After 6 months of follow-up
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 8 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Ferran Barbé, MD principal investigator
Sociedad Española de Neumología y Cirugía Torácica
Manuel Sanchez-de-la-Torre, PhD principal investigator
Consorcio Centro de Investigación Biomédica en Red (CIBER)
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 Hypertension, 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 2 inclusion and 4 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 2019. 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?
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?
Modeling the cardiovascular (CV) disease risk in patients with obstructive sleep apnea (OSA) through the analysis of the number and specific biomarkers. (time frame: Baseline). 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 8 Apr 2019.