ClinicalTrials.gg
Sign In
RecruitingNCT06463561CPAPLIPUpdated Jul 15, 2024

CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea

A Phase 4 interventional study of Continuous positive airway pressure and Hygienic-dietary recommendations and daily physical activity promotion in Sleep Apnea, Dyslipidemias and Hyperuricemia, sponsored by Hospital Universitario La Paz. Recruiting at 1 site in Spain. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Hospital Universitario La Paz · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Study 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.

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:

  1. Conventional hygienic-dietary recommendations and promotion of daily physical activity.
  2. 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.
02

Conditions studied

  • Sleep Apnea
  • Dyslipidemias
  • Hyperuricemia
03

In context

Sleep Apnea Syndromes

2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.

This study's planned enrollment of 220 is above the median of 53 across 1,400 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Hospital Universitario La Paz is the lead sponsor of 55 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Active comparator
    Control group

    Conventional hygienic-dietary recommendations and promotion of daily physical activity

    Other: Hygienic-dietary recommendations and daily physical activity promotion

  • Experimental
    CPAP group

    Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP)

    Device: Continuous positive airway pressure · Other: Hygienic-dietary recommendations and daily physical activity promotion

Interventions

  • DeviceContinuous positive airway pressure

    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.

  • OtherHygienic-dietary recommendations and daily physical activity promotion

    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.

06

What researchers measure

Primary outcomes

  1. CPAP effect on lipid profile

    Comparison of 12-months change from baseline in the plasma level of LDL-cholesterol between the two study groups

    Time frame: 12 months

  2. 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

    Time frame: 12 months

  3. 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

    Time frame: 12 months

  4. CPAP effect on lipid profile-4

    Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups

    Time frame: 12 months

Secondary outcomes

  1. CPAP effect on uric acid

    Comparison of 12-months change from baseline in the plasma level of uric acid between the two study groups

    Time frame: 12 months

  2. Medium-term CPAP effect on insulin resistance

    Comparison of 6-months change from baseline in the HOMA index between the two study groups

    Time frame: 6 months

  3. Long-term CPAP effect on insulin resistance

    Comparison of 12-months change from baseline in the HOMA index between the two study groups

    Time frame: 12 months

  4. CPAP effect on cardiovascular risk

    Comparison of 12-months change from baseline in the cardiovascular risk score between the two study groups

    Time frame: 12 months

  5. CPAP effect on glycemic control

    Comparison of 12-months change from baseline in the plasma level of HbA1c between the two study groups

    Time frame: 12 months

  6. 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

    Time frame: 12 months

  7. CPAP effect on sleepiness

    Comparison of 12-months change from baseline in the Epworth sleepiness scale between the two study groups

    Time frame: 12 months

  8. CPAP effect on health-related quality of life

    Comparison of 12-months change from baseline in the EuroQoL score between the two study groups

    Time frame: 12 months

  9. 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

    Time frame: 12 months

  10. CPAP effect on daily physical activity

    Comparison of 12-months change from baseline in the iPAQ score between the two study groups

    Time frame: 12 months

  11. 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

    Time frame: 12 months

  12. 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

    Time frame: 12 months

  13. CPAP effect on sympathetic tone

    Comparison of 12-months change from baseline in the plasma level of neuropeptide Y between the two study groups

    Time frame: 12 months

  14. 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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario del Henares
    Coslada, Madrid 28822, Spain
    • Angeles Ruiz-Cobos, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06463561
Lead sponsor
Hospital Universitario La Paz
Collaborators
Hospital Universitario del Henares
Responsible party
Francisco Garcia-Rio (PhD, Hospital Universitario La Paz) — Principal investigator
First posted
Jun 18, 2024
Start date
Jul 12, 2024
Primary completion
Jul 30, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Jul 15, 2024

Study contacts

Francisco Garcia-Rio, MD
Contact
fgr01m@gmail.com
+34639911718
Francisco Garcia-Rio
Contact
fgr01m@gmail.com
+34639911718
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
Raquel Casitas, MD
principal investigator · Hospital Universitario La Paz
Marina Blanco Cruz, ND
principal investigator · Hospital Universitario del Henares

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Sleep Apnea Syndromes →

Other studies from this sponsor

Hospital Universitario La Paz

Start the discussion