Sleep ApneaNCT02557412
Effect of Nasal CPAP on Lipid Profile in Patients With Dyslipidaemia and Sleep Apnea
A study testing Continuous positive airway pressure, Intensive lifestyle intervention and Conventional treatment in people with Sleep Apnea and Dyslipidaemia, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Sleep Apnea, Dyslipidaemia
- What is being tested?
- Continuous positive airway pressure, Intensive lifestyle intervention and Conventional treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Dec 2022
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dyslipidemia: The existence of a previous clinical diagnostic of dyslipidemia associated with lipid-lowering therapy. It is also considered patients who have an altered analytical, using the following cutoffs: total cholesterol ≥ 200 mg / dl, triglycerides ≥ 180 mg / dl, HDL-cholesterol ≤ 40 mg / dl or LDL-cholesterol ≥ 150 mg / dl. Lipid-lowering treatment and diet, stable in the last month.
- A concentration of LDL-cholesterol above 100 mg / dl, in the month prior to inclusion.
- An apnea-hypopnea index between 5-30 h-1
Who cannot join
- Apnea-hypopnea index of less than 5 h-1 or greater than 30 h-1.
- Predominance of central apneas and hypopneas, defined as more than 25% of all respiratory events.
- Professional drivers, risk profession or respiratory failure (according to criteria of the clinical pathway for diagnosis and treatment of sleep-disordered breathing).
- Very excessive daytime sleepiness (Epworth Sleepiness Scale> 18).
- Morbid obesity (BMI> 40 kg / m2).
- Prior treatment with CPAP.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
About this study
Official title: Long-term Effect of Nasal Continuous Positive Airway Pressure on Lipid Profile in Patients With Dyslipidaemia and Mild-moderate Obstructive Sleep Apnea
OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA).
Secondary objectives:
Read more
- Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA.
- Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA.
DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment.
STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.
Sample size. 38 patients who completed the test in each treatment arm.
TREATMENT
Patients will be randomized to one of the following treatment arms form:
- hygiene and dietary recommendations.
- lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
- Treatment with positive airway pressure (CPAP).
ENDPOINTS:
Efficacy endpoints.
- Primary endpoint: LDL-cholesterol.
- Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP).
- Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin).
- Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI), thyroid-stimulating hormone (TSH).
- Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ).
Security endpoints.
- Notification of clinical adverse events.
- Compliance with CPAP (average hours use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
Read the detailed description
OBJECTIVES
Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA).
Secondary objectives:
- Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA.
- Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA.
- Analyze the impact of supplemental CPAP treatment on glycemic control and the concentration of hsCRP in patients with dyslipidemia and mild-moderate OSA.
- Establish the impact of supplemental CPAP treatment on quality of life related to health of patients with dyslipidemia and mild-moderate OSA.
- Evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and regulating hormones intake in patients with dyslipidemia and mild-moderate OSA.
- Correlate CPAP induced changes in lipid levels with the changes produced in the basal inflammatory response, oxidative stress, sympathetic activity and intake regulating hormones.
- Compare the effect of CPAP with promotion of daily physical activity on lipid profile in patients with dyslipidemia and mild-moderate OSA.
- Identify the subgroup of patients with uncontrolled dyslipidemia and mild-moderate OSA in wich six months of treatment with CPAP achieve a more pronounced reduction in blood lipids.
DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment.
STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.
Sample size. 38 patients who completed the test in each treatment arm.
TREATMENT
Patients will be randomized to one of the following treatment arms form:
- hygiene and dietary recommendations.
- lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
- Treatment with positive airway pressure (CPAP).
ENDPOINTS Efficacy endpoints.
- Primary endpoint: LDL-cholesterol.
- Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP).
- Systemic Biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin).
- Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and HOMA and QUICKI indexes, TSH.
- Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.
Security endpoints.
- Notification of clinical adverse events.
- Compliance with CPAP (average hours use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
STATISTICAL PROCEDURES Data will be expressed as mean ± standard deviation, median (interquartile range) or percent, depending on type and distribution. For comparison between groups, or t-Student test, or the Mann-Whitney U-test or chi-square test will be used, as appropriate. The relationships between variables will be analyzed by Pearson correlation and multiple linear regression.
The treatment effect will be evaluated by analysis of variance for repeated measures with post-hoc multiple comparisons, using the Bonferroni test. A model of multiple logistic regression will be applied to determine the variables associated with treatment response. P values will be considered statistically significant <0.05.
- Conditions
- Sleep Apnea, Dyslipidaemia
- Being tested
- Continuous positive airway pressure, Intensive lifestyle intervention, Conventional treatment
- Medical subject headings
- Sleep Apnea Syndromes, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Treatment with nasal CPAP. Treatment begins with an empirical pressure of 8 cmH2O and in a period of three weeks, the pressure is adjusted by automatic titration with AutoSet II (ResMed) device.
Intensive lifestyle interventionBehavioural
Specific alimentary plan (carbohydrates: 40-45%; fats: 25-35% [saturated fats <7% monounsaturated fats up to 20% and polyunsaturated fats <10% ] and proteins: 15-20%) and recommendation to increase daily physical activity, setting a target walking 10,000 steps a day. The patients will be provided with a pedometer and will asked to fill out a form with the steps that they walked each day. At each visit, the distance walked will be reviewed and the target set will be remarked.
Conventional treatmentOther
Hygiene and diet recommendations on sleep
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Placebo comparator | Hygiene and diet recommendations on sleep. Receives: Other: Conventional treatment |
| Intensive lifestyle intervention | Active comparator | Lifestyle intervention will consist of a structured intervention in a specific alimentary plan (carbohydrates: 40-45%; fats: 25-35% [saturated fats <7% monounsaturated fats up to 20% and polyunsaturated fats <10% ] and proteins: 15-20%), which will be repeated in each review. Also, be recommended to increase daily physical activity, setting a target walking 10,000 steps a day. To do this, to patients assigned to this treatment arm, will be provided with a pedometer and will asked to fill out a form with the steps that they walked each day. At each visit, the distance walked will be reviewed and the target set will be remarked. Receives: Behavioral: Intensive lifestyle intervention |
| Continuous positive airway pressure | Active comparator | Treatment with nasal continuous positive airway pressure (CPAP). Treatment begins with an empirical pressure of 8 centimetres of water (cmH2O) and in a period of three weeks, the pressure is adjusted by titration with an automatic positive airway pressure device (AutoSet II, ResMed). Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol
LDL-cholesterol level in peripheral blood
Measured: 6 months
Secondary outcomes (9)
Lipid profile
Total cholesterol, HDL-cholesterol, and triglycerides
Measured: 6 months
Systemic biomarkers
C-reactive protein, IL-6, IL-8, TNF-α, 8-isoprostane, endothelin, VCAM-1, ICAM-1, neuropeptide Y, leptin, orexin and ghrelin.
Measured: 6 months
Glycated hemoglobin
Glycated hemoglobin (HbA1c).
Measured: 6 months
Insulin resistance
HOMA and QUICKI indexes.
Measured: 6 months
Health-related quality of life
SF-12, EuroQoL and FOSQ questionnaires (generic and specific health-related quality of life).
Measured: 6 months
Daily physical activity
IPAQ questionnaire.
Measured: 6 months
Clinical adverse events
Measured: 6 months
CPAP compliance
Mean of CPAP use per night (h/night)
Measured: 6 months
Sleepiness
Epworth Sleepiness Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Limitations to recruitment related to COVID
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias
- Responsible party
- Principal investigator, Francisco Garcia-Rio, Hospital Universitario La Paz
- Investigators
- Francisco Garcia-Rio, MD, Study director, Hospital Universitario La Paz, IdiPAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557412
- Sponsor's protocol ID
- PINML01
- Status last verified
- Mar 2023
- First submitted
- 25 Jun 2015
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Nasal Continuous Positive Airway Pressure on Lipid Profile in Patients With Dyslipidaemia and Mild-moderate Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02557412
- Acronym / sponsor ID
- PINML01
- Conditions
- Sleep Apnea, Dyslipidaemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Limitations to recruitment related to COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias
- Study start
- May 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Sep 2015 (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.
OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA).
Secondary objectives:
- Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA.
- Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA.
DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment.
STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.
Sample size. 38 patients who completed the test in each treatment arm.
TREATMENT
Patients will be randomized to one of the following treatment arms form:
- hygiene and dietary recommendations.
- lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
- Treatment with positive airway pressure (CPAP).
ENDPOINTS:
Efficacy endpoints.
- Primary endpoint: LDL-cholesterol.
- Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP).
- Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin).
- Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI), thyroid-stimulating hormone (TSH).
- Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ).
Security endpoints.
- Notification of clinical adverse events.
- Compliance with CPAP (average hours use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
Detailed description
OBJECTIVES
Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA).
Secondary objectives:
- Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA.
- Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA.
- Analyze the impact of supplemental CPAP treatment on glycemic control and the concentration of hsCRP in patients with dyslipidemia and mild-moderate OSA.
- Establish the impact of supplemental CPAP treatment on quality of life related to health of patients with dyslipidemia and mild-moderate OSA.
- Evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and regulating hormones intake in patients with dyslipidemia and mild-moderate OSA.
- Correlate CPAP induced changes in lipid levels with the changes produced in the basal inflammatory response, oxidative stress, sympathetic activity and intake regulating hormones.
- Compare the effect of CPAP with promotion of daily physical activity on lipid profile in patients with dyslipidemia and mild-moderate OSA.
- Identify the subgroup of patients with uncontrolled dyslipidemia and mild-moderate OSA in wich six months of treatment with CPAP achieve a more pronounced reduction in blood lipids.
DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment.
STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.
Sample size. 38 patients who completed the test in each treatment arm.
TREATMENT
Patients will be randomized to one of the following treatment arms form:
- hygiene and dietary recommendations.
- lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
- Treatment with positive airway pressure (CPAP).
ENDPOINTS Efficacy endpoints.
- Primary endpoint: LDL-cholesterol.
- Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP).
- Systemic Biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin).
- Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and HOMA and QUICKI indexes, TSH.
- Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.
Security endpoints.
- Notification of clinical adverse events.
- Compliance with CPAP (average hours use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
STATISTICAL PROCEDURES Data will be expressed as mean ± standard deviation, median (interquartile range) or percent, depending on type and distribution. For comparison between groups, or t-Student test, or the Mann-Whitney U-test or chi-square test will be used, as appropriate. The relationships between variables will be analyzed by Pearson correlation and multiple linear regression.
The treatment effect will be evaluated by analysis of variance for repeated measures with post-hoc multiple comparisons, using the Bonferroni test. A model of multiple logistic regression will be applied to determine the variables associated with treatment response. P values will be considered statistically significant <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Placebo comparator | Other: Conventional treatmentHygiene and diet recommendations on sleep. |
| Intensive lifestyle intervention | Active comparator | Behavioral: Intensive lifestyle interventionLifestyle intervention will consist of a structured intervention in a specific alimentary plan (carbohydrates: 40-45%; fats: 25-35% [saturated fats <7% monounsaturated fats up to 20% and polyunsaturated fats <10% ] and proteins: 15-20%), which will be repeated in each review. Also, be recommended to increase daily physical activity, setting a target walking 10,000 steps a day. To do this, to patients assigned to this treatment arm, will be provided with a pedometer and will asked to fill out a form with the steps that they walked each day. At each visit, the distance walked will be reviewed and the target set will be remarked. |
| Continuous positive airway pressure | Active comparator | Device: Continuous positive airway pressureTreatment with nasal continuous positive airway pressure (CPAP). Treatment begins with an empirical pressure of 8 centimetres of water (cmH2O) and in a period of three weeks, the pressure is adjusted by titration with an automatic positive airway pressure device (AutoSet II, ResMed). |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of dyslipidemia: The existence of a previous clinical diagnostic of dyslipidemia associated with lipid-lowering therapy. It is also considered patients who have an altered analytical, using the following cutoffs: total cholesterol ≥ 200 mg / dl, triglycerides ≥ 180 mg / dl, HDL-cholesterol ≤ 40 mg / dl or LDL-cholesterol ≥ 150 mg / dl. Lipid-lowering treatment and diet, stable in the last month.
- A concentration of LDL-cholesterol above 100 mg / dl, in the month prior to inclusion.
- An apnea-hypopnea index between 5-30 h-1
Key exclusion criteria (6 listed)
- Apnea-hypopnea index of less than 5 h-1 or greater than 30 h-1.
- Predominance of central apneas and hypopneas, defined as more than 25% of all respiratory events.
- Professional drivers, risk profession or respiratory failure (according to criteria of the clinical pathway for diagnosis and treatment of sleep-disordered breathing).
- Very excessive daytime sleepiness (Epworth Sleepiness Scale> 18).
- Morbid obesity (BMI> 40 kg / m2).
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 pressureTreatment with nasal CPAP. Treatment begins with an empirical pressure of 8 cmH2O and in a period of three weeks, the pressure is adjusted by automatic titration with AutoSet II (ResMed) device. | Device | Continuous positive airway pressure |
| Intensive lifestyle interventionSpecific alimentary plan (carbohydrates: 40-45%; fats: 25-35% [saturated fats <7% monounsaturated fats up to 20% and polyunsaturated fats <10% ] and proteins: 15-20%) and recommendation to increase daily physical activity, setting a target walking 10,000 steps a day. The patients will be provided with a pedometer and will asked to fill out a form with the steps that they walked each day. At each visit, the distance walked will be reviewed and the target set will be remarked. | Behavioural | Intensive lifestyle intervention |
| Conventional treatmentHygiene and diet recommendations on sleep | Other | Conventional treatment |
Primary outcome
LDL-cholesterol
Time frame: 6 months
LDL-cholesterol level in peripheral blood
9 secondary outcomes
Lipid profile
Time frame: 6 months
Systemic biomarkers
Time frame: 6 months
Glycated hemoglobin
Time frame: 6 months
Insulin resistance
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Daily physical activity
Time frame: 6 months
Clinical adverse events
Time frame: 6 months
CPAP compliance
Time frame: 6 months
Sleepiness
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
Francisco Garcia-Rio, MD study director
Hospital Universitario La Paz, IdiPAZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure, Intensive lifestyle intervention and Conventional treatment in people with Sleep Apnea and Dyslipidaemia, run by Hospital Universitario La Paz 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 Mar 2023. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
LDL-cholesterol (time frame: 6 months). 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 6 Mar 2023.