Effect of Nasal CPAP on Lipid Profile in Patients With Dyslipidaemia and Sleep Apnea

March 2, 2023 updated by: Francisco Garcia-Rio, Hospital Universitario La Paz

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:

  • 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:

  1. hygiene and dietary recommendations.
  2. lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
  3. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. hygiene and dietary recommendations.
  2. lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
  3. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805
        • Hospital Universitario Príncipe de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Conventional treatment
Hygiene and diet recommendations on sleep.
Other: Conventional treatment
Hygiene and diet recommendations on sleep
Active Comparator: Intensive lifestyle intervention
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.
Behavioral: Intensive lifestyle intervention
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.
Active Comparator: Continuous positive airway pressure
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).
Device: Continuous positive airway pressure
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
LDL-cholesterol
Time Frame: 6 months
LDL-cholesterol level in peripheral blood
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 6 months
Total cholesterol, HDL-cholesterol, and triglycerides
6 months
Systemic biomarkers
Time Frame: 6 months
C-reactive protein, IL-6, IL-8, TNF-α, 8-isoprostane, endothelin, VCAM-1, ICAM-1, neuropeptide Y, leptin, orexin and ghrelin.
6 months
Glycated hemoglobin
Time Frame: 6 months
Glycated hemoglobin (HbA1c).
6 months
Insulin resistance
Time Frame: 6 months
HOMA and QUICKI indexes.
6 months
Health-related quality of life
Time Frame: 6 months
SF-12, EuroQoL and FOSQ questionnaires (generic and specific health-related quality of life).
6 months
Daily physical activity
Time Frame: 6 months
IPAQ questionnaire.
6 months
Clinical adverse events
Time Frame: 6 months
6 months
CPAP compliance
Time Frame: 6 months
Mean of CPAP use per night (h/night)
6 months
Sleepiness
Time Frame: 6 months
Epworth Sleepiness Scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario La Paz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario Principe de Asturias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PINML01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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