Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:01 PM
Study NCT ID:
NCT06463561
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPAP effect on lipid profile', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of LDL-cholesterol between the two study groups'}, {'measure': 'CPAP effect on lipid profile-2', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of HDL-cholesterol between the two study groups'}, {'measure': 'CPAP effect on lipid profile-3', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of total cholesterol between the two study groups'}, {'measure': 'CPAP effect on lipid profile-4', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups'}], 'secondaryOutcomes': [{'measure': 'CPAP effect on uric acid', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of uric acid between the two study groups'}, {'measure': 'Medium-term CPAP effect on insulin resistance', 'timeFrame': '6 months', 'description': 'Comparison of 6-months change from baseline in the HOMA index between the two study groups'}, {'measure': 'Long-term CPAP effect on insulin resistance', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the HOMA index between the two study groups'}, {'measure': 'CPAP effect on cardiovascular risk', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the cardiovascular risk score between the two study groups'}, {'measure': 'CPAP effect on glycemic control', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of HbA1c between the two study groups'}, {'measure': 'CPAP effect on C-reactive protein', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of C-reactive protein between the two study groups'}, {'measure': 'CPAP effect on sleepiness', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the Epworth sleepiness scale between the two study groups'}, {'measure': 'CPAP effect on health-related quality of life', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the EuroQoL score between the two study groups'}, {'measure': 'CPAP effect on health-related quality of life-2', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the SF-12 score between the two study groups'}, {'measure': 'CPAP effect on daily physical activity', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the iPAQ score between the two study groups'}, {'measure': 'CPAP effect on inflammatory cytokines', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma levels of IL-6, IL-8 and TNF-α between the two study groups'}, {'measure': 'CPAP effect on oxidative stress biomarkers', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of 8-isoprostane between the two study groups'}, {'measure': 'CPAP effect on sympathetic tone', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma level of neuropeptide Y between the two study groups'}, {'measure': 'CPAP effect on intake-regulating hormones', 'timeFrame': '12 months', 'description': 'Comparison of 12-months change from baseline in the plasma levels of leptin, orexin A/hypocretin 1 and ghrelin between the two study groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea', 'Dyslipidemias', 'Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia.\n\nObjectives:\n\nMain 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.\n\nSecondary objectives:\n\n* 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.\n* To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA.\n* To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA.\n* To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA.\n* To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA.\n* 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.\n* 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.\n* 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.\n\nDesign Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment.\n\nStudy 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.\n\nSample size: 110 patients in each treatment arm.\n\nTreatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms:\n\n1. Conventional hygienic-dietary recommendations and promotion of daily physical activity.\n2. Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP).\n\nEfficiency variables\n\n* Main variables: LDL-cholesterol and uric acid.\n* Total cholesterol, HDL-cholesterol and triglycerides.\n* Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein.\n* 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).\n* Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.\n\nSafety variables\n\n* Clinical adverse event reporting.\n* CPAP compliance (average hours of use per day).\n* Epworth Sleepiness Questionnaire.\n* Development of cardiovascular events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects from 35 to 80 years old\n* 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.\n* Moderate-severe sleep apnea, defined by AHI \\> 15 h-1 .\n\nExclusion Criteria:\n\n* Predominance of central apneas-hypopneas, defined as more than 25% of total respiratory events.\n* 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.\n* Professional drivers, at-risk profession or respiratory insufficiency (according to criteria of the clinical pathway for the diagnosis and treatment of sleep-disordered breathing).\n* Pretreatment with CPAP'}, 'identificationModule': {'nctId': 'NCT06463561', 'acronym': 'CPAPLIP', 'briefTitle': 'CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '082024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Conventional hygienic-dietary recommendations and promotion of daily physical activity', 'interventionNames': ['Other: Hygienic-dietary recommendations and daily physical activity promotion']}, {'type': 'EXPERIMENTAL', 'label': 'CPAP group', 'description': 'Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP)', 'interventionNames': ['Device: Continuous positive airway pressure', 'Other: Hygienic-dietary recommendations and daily physical activity promotion']}], 'interventions': [{'name': 'Continuous positive airway pressure', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['CPAP group']}, {'name': 'Hygienic-dietary recommendations and daily physical activity promotion', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['CPAP group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28822', 'city': 'Coslada', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Angeles Ruiz-Cobos, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario del Henares', 'geoPoint': {'lat': 40.42378, 'lon': -3.56129}}], 'centralContacts': [{'name': 'Francisco Garcia-Rio, MD', 'role': 'CONTACT', 'email': 'fgr01m@gmail.com', 'phone': '+34639911718'}, {'name': 'Francisco Garcia-Rio', 'role': 'CONTACT', 'email': 'fgr01m@gmail.com', 'phone': '+34639911718'}], 'overallOfficials': [{'name': 'Maria Angeles Ruiz-Cobos, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario del Henares'}, {'name': 'Ana De la Rocha Prieto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario del Henares'}, {'name': 'Julia Dorta Díez de la Lastra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario del Henares'}, {'name': 'Raquel Casitas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz'}, {'name': 'Marina Blanco Cruz, ND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario del Henares'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario del Henares', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Francisco Garcia-Rio', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}