Sleep ApneaPhase 4CPAPLIPNCT06463561
CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea
A Phase 4 study testing Continuous positive airway pressure and Hygienic-dietary recommendations and daily physical activity promotion in people with Sleep Apnea and Dyslipidemias, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia. Objectives: Main objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Sleep Apnea, Dyslipidemias, Hyperuricemia
- What is being tested?
- Continuous positive airway pressure and Hygienic-dietary recommendations and daily physical activity promotion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2024to 31 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects from 35 to 80 years old
- Diagnosis of dyslipidemia. It will be considered as such, the existence of a previous clinical record of a diagnosis of dyslipidemia associated with treatment with lipidlowering agents, treatment with lipid-lowering agents or the presence of an altered blood test in the last two months, using the following cut-off points: total cholesterol ≥ 200 mg/dl, triglycerides ≥ 180 mg/dl, HDL-cholesterol ≤ 40 mg/dl or LDL-cholesterol ≥ 150 mg/dl.
- Moderate-severe sleep apnea, defined by AHI > 15 h-1 .
Who cannot join
- Predominance of central apneas-hypopneas, defined as more than 25% of total respiratory events.
- Patients with indications for CPAP treatment according to the International Sleep Consensus: hypertensive, excessive daytime sleepiness (Epworth Sleepiness Scale > 11) or impaired sleep-related quality of life considered relevant by their regular physician.
- Professional drivers, at-risk profession or respiratory insufficiency (according to criteria of the clinical pathway for the diagnosis and treatment of sleep-disordered breathing).
- Pretreatment with CPAP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario del Henares
Coslada, Madrid, 28822
Angeles Ruiz-Cobos, MD
About this study
Official title: Effect of 12 Months of Treatment With Continuous Positive Airway Pressure on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea. A Randomized, Open-labell, Parallel Clinical Trial
Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia.
Objectives:
Read more
Main objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA.
Secondary objectives:
- To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA.
- To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA.
- To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA.
- To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA.
- To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA.
- To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA.
- To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones.
- To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid.
Design Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment.
Study population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications.
Sample size: 110 patients in each treatment arm.
Treatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms:
- Conventional hygienic-dietary recommendations and promotion of daily physical activity.
- Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP).
Efficiency variables
- Main variables: LDL-cholesterol and uric acid.
- Total cholesterol, HDL-cholesterol and triglycerides.
- Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein.
- 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).
- Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.
Safety variables
- Clinical adverse event reporting.
- CPAP compliance (average hours of use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
- Conditions
- Sleep Apnea, Dyslipidemias, Hyperuricemia
- Being tested
- Continuous positive airway pressure, Hygienic-dietary recommendations and daily physical activity promotion
- Medical subject headings
- Sleep Apnea Syndromes, Dyslipidemias, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Treatment will start with an empirical pressure of 8 cmH2O and, within a maximum of 3 weeks, the pressure will be adjusted by means of automatic titration, establishing the pressure corresponding to the 95th percentile.
Hygienic-dietary recommendations and daily physical activity promotionOther
Hygienic-dietary recommendations on sleep and intervention for the promotion of daily physical activity, establishing walking as a goal 10,000 steps per day. To do this, they will be provided with a pedometer and asked to fill out a form with the steps walked each day. At each visit, the distance walked will be reviewed and the goal set will be reiterated.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Conventional hygienic-dietary recommendations and promotion of daily physical activity Receives: Other: Hygienic-dietary recommendations and daily physical activity promotion |
| CPAP group | Experimental | Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP) Receives: Device: Continuous positive airway pressure; Other: Hygienic-dietary recommendations and daily physical activity promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP effect on lipid profile
Comparison of 12-months change from baseline in the plasma level of LDL-cholesterol between the two study groups
Measured: 12 months
CPAP effect on lipid profile-2
Comparison of 12-months change from baseline in the plasma level of HDL-cholesterol between the two study groups
Measured: 12 months
CPAP effect on lipid profile-3
Comparison of 12-months change from baseline in the plasma level of total cholesterol between the two study groups
Measured: 12 months
CPAP effect on lipid profile-4
Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups
Measured: 12 months
Secondary outcomes (14)
CPAP effect on uric acid
Comparison of 12-months change from baseline in the plasma level of uric acid between the two study groups
Measured: 12 months
Medium-term CPAP effect on insulin resistance
Comparison of 6-months change from baseline in the HOMA index between the two study groups
Measured: 6 months
Long-term CPAP effect on insulin resistance
Comparison of 12-months change from baseline in the HOMA index between the two study groups
Measured: 12 months
CPAP effect on cardiovascular risk
Comparison of 12-months change from baseline in the cardiovascular risk score between the two study groups
Measured: 12 months
CPAP effect on glycemic control
Comparison of 12-months change from baseline in the plasma level of HbA1c between the two study groups
Measured: 12 months
CPAP effect on C-reactive protein
Comparison of 12-months change from baseline in the plasma level of C-reactive protein between the two study groups
Measured: 12 months
CPAP effect on sleepiness
Comparison of 12-months change from baseline in the Epworth sleepiness scale between the two study groups
Measured: 12 months
CPAP effect on health-related quality of life
Comparison of 12-months change from baseline in the EuroQoL score between the two study groups
Measured: 12 months
CPAP effect on health-related quality of life-2
Comparison of 12-months change from baseline in the SF-12 score between the two study groups
Measured: 12 months
CPAP effect on daily physical activity
Comparison of 12-months change from baseline in the iPAQ score between the two study groups
Measured: 12 months
CPAP effect on inflammatory cytokines
Comparison of 12-months change from baseline in the plasma levels of IL-6, IL-8 and TNF-α between the two study groups
Measured: 12 months
CPAP effect on oxidative stress biomarkers
Comparison of 12-months change from baseline in the plasma level of 8-isoprostane between the two study groups
Measured: 12 months
CPAP effect on sympathetic tone
Comparison of 12-months change from baseline in the plasma level of neuropeptide Y between the two study groups
Measured: 12 months
CPAP effect on intake-regulating hormones
Comparison of 12-months change from baseline in the plasma levels of leptin, orexin A/hypocretin 1 and ghrelin between the two study groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start12 Jul 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario del Henares
- Responsible party
- Principal investigator, Francisco Garcia-Rio, Hospital Universitario La Paz
- Investigators
- Maria Angeles Ruiz-Cobos, MD, Study chair, Hospital Universitario del HenaresAna De la Rocha Prieto, MD, Principal investigator, Hospital Universitario del HenaresJulia Dorta Díez de la Lastra, MD, Principal investigator, Hospital Universitario del HenaresRaquel Casitas, MD, Principal investigator, Hospital Universitario La PazMarina Blanco Cruz, ND, Principal investigator, Hospital Universitario del Henares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463561
- Sponsor's protocol ID
- 082024
- Acronym
- CPAPLIP
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 12 Months of Treatment With Continuous Positive Airway Pressure on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea. A Randomized, Open-labell, Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT06463561
- Acronym / sponsor ID
- CPAPLIP / 082024
- Conditions
- Sleep Apnea, Dyslipidemias, Hyperuricemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario del Henares
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 18 Jun 2024 (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.
Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia.
Objectives:
Main objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA.
Secondary objectives:
- To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA.
- To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA.
- To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA.
- To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA.
- To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA.
- To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA.
- To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones.
- To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid.
Design Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment.
Study population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications.
Sample size: 110 patients in each treatment arm.
Treatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms:
- Conventional hygienic-dietary recommendations and promotion of daily physical activity.
- Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP).
Efficiency variables
- Main variables: LDL-cholesterol and uric acid.
- Total cholesterol, HDL-cholesterol and triglycerides.
- Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein.
- 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).
- Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.
Safety variables
- Clinical adverse event reporting.
- CPAP compliance (average hours of use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Hygienic-dietary recommendations and daily physical activity promotionConventional hygienic-dietary recommendations and promotion of daily physical activity |
| CPAP group | Experimental | Device: Continuous positive airway pressure, Other: Hygienic-dietary recommendations and daily physical activity promotionConventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects from 35 to 80 years old
- Diagnosis of dyslipidemia. It will be considered as such, the existence of a previous clinical record of a diagnosis of dyslipidemia associated with treatment with lipidlowering agents, treatment with lipid-lowering agents or the presence of an altered blood test in the last two months, using the following cut-off points: total cholesterol ≥ 200 mg/dl, triglycerides ≥ 180 mg/dl, HDL-cholesterol ≤ 40 mg/dl or LDL-cholesterol ≥ 150 mg/dl.
- Moderate-severe sleep apnea, defined by AHI > 15 h-1 .
Key exclusion criteria (4 listed)
- Predominance of central apneas-hypopneas, defined as more than 25% of total respiratory events.
- Patients with indications for CPAP treatment according to the International Sleep Consensus: hypertensive, excessive daytime sleepiness (Epworth Sleepiness Scale > 11) or impaired sleep-related quality of life considered relevant by their regular physician.
- Professional drivers, at-risk profession or respiratory insufficiency (according to criteria of the clinical pathway for the diagnosis and treatment of sleep-disordered breathing).
- Pretreatment with CPAP
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 will start with an empirical pressure of 8 cmH2O and, within a maximum of 3 weeks, the pressure will be adjusted by means of automatic titration, establishing the pressure corresponding to the 95th percentile. | Device | CPAP group |
| Hygienic-dietary recommendations and daily physical activity promotionHygienic-dietary recommendations on sleep and intervention for the promotion of daily physical activity, establishing walking as a goal 10,000 steps per day. To do this, they will be provided with a pedometer and asked to fill out a form with the steps walked each day. At each visit, the distance walked will be reviewed and the goal set will be reiterated. | Other | CPAP group, Control group |
Primary outcome
CPAP effect on lipid profile
Time frame: 12 months
Comparison of 12-months change from baseline in the plasma level of LDL-cholesterol between the two study groups
CPAP effect on lipid profile-2
Time frame: 12 months
Comparison of 12-months change from baseline in the plasma level of HDL-cholesterol between the two study groups
CPAP effect on lipid profile-3
Time frame: 12 months
Comparison of 12-months change from baseline in the plasma level of total cholesterol between the two study groups
CPAP effect on lipid profile-4
Time frame: 12 months
Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups
14 secondary outcomes
CPAP effect on uric acid
Time frame: 12 months
Medium-term CPAP effect on insulin resistance
Time frame: 6 months
Long-term CPAP effect on insulin resistance
Time frame: 12 months
CPAP effect on cardiovascular risk
Time frame: 12 months
CPAP effect on glycemic control
Time frame: 12 months
CPAP effect on C-reactive protein
Time frame: 12 months
CPAP effect on sleepiness
Time frame: 12 months
CPAP effect on health-related quality of life
Time frame: 12 months
CPAP effect on health-related quality of life-2
Time frame: 12 months
CPAP effect on daily physical activity
Time frame: 12 months
CPAP effect on inflammatory cytokines
Time frame: 12 months
CPAP effect on oxidative stress biomarkers
Time frame: 12 months
CPAP effect on sympathetic tone
Time frame: 12 months
CPAP effect on intake-regulating hormones
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Maria Angeles Ruiz-Cobos, MD study chair
Hospital Universitario del Henares
Ana De la Rocha Prieto, MD principal investigator
Hospital Universitario del Henares
Julia Dorta Díez de la Lastra, MD principal investigator
Hospital Universitario del Henares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous positive airway pressure and Hygienic-dietary recommendations and daily physical activity promotion in people with Sleep Apnea and Dyslipidemias, 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 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: looking for participants now, as of the sponsor's last update on 15 Jul 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Garcia-Rio, MD (+34639911718, fgr01m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP effect on lipid profile (time frame: 12 months). The study lists 4 primary outcomes in all. 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 15 Jul 2024.