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

NCT06463561 | Recruiting Phase 4

• 1 other identifier: 082024
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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:
• 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).
• 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

Outcome Measures

Primary Outcomes (4)

• CPAP effect on lipid profile

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

  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

  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

  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

  12 months

Secondary Outcomes (14)

• CPAP effect on uric acid

  12 months

• Medium-term CPAP effect on insulin resistance

  6 months

• Long-term CPAP effect on insulin resistance

  12 months

• CPAP effect on cardiovascular risk

  12 months

• CPAP effect on glycemic control

  12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Conventional hygienic-dietary recommendations and promotion of daily physical activity

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)

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

Interventions

Continuous positive airway pressure DEVICE

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.

CPAP group

Hygienic-dietary recommendations and daily physical activity promotion OTHER

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.

CPAP group; Control group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• Hospital Universitario del Henares: collaborator

Study Sites (1)

Hospital Universitario del Henares

Coslada, Madrid, 28822, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Dyslipidemias; Hyperuricemia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Maria Angeles Ruiz-Cobos, MD

  Hospital Universitario del Henares

  STUDY CHAIR

• Ana De la Rocha Prieto, MD

  Hospital Universitario del Henares

  PRINCIPAL INVESTIGATOR

• Julia Dorta Díez de la Lastra, MD

  Hospital Universitario del Henares

  PRINCIPAL INVESTIGATOR

• Raquel Casitas, MD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Marina Blanco Cruz, ND

  Hospital Universitario del Henares

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Garcia-Rio, MD

CONTACT

+34639911718; fgr01m@gmail.com

Francisco Garcia-Rio

CONTACT

+34639911718; fgr01m@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 15, 2024

Record last verified: 2024-06

Locations

ES (1)