protocolSection identificationModule nctId: NCT06370806, orgStudyIdInfo id: INTERAPNEA-Women, briefTitle: Lifestyle Intervention for Obstructive Sleep Apnea in Women, acronym: INTERAPNEA-W, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Universidad de Granada, class: OTHER, collaborators name: Fundación BBVA, collaborators name: Universidad Loyola Andalucia, descriptionModule briefSummary: Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Weight loss and lifestyle intervention, outcomesModule primaryOutcomes measure: Apnoea-hypopnoea index (AHI), secondaryOutcomes measure: Oxygen desaturation index (ODI), secondaryOutcomes measure: Oxygen saturation (SaO2) mean, secondaryOutcomes measure: Oxygen saturation (SaO2) nadir, secondaryOutcomes measure: Sleep efficiency, secondaryOutcomes measure: Light sleep (N1 and N2 stages), secondaryOutcomes measure: Deep sleep (N3 stage), secondaryOutcomes measure: Rapid eye movement (REM) sleep, secondaryOutcomes measure: Excessive daytime sleepiness (EDS), secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Wake After Sleep Onset (WASO), secondaryOutcomes measure: Fat mass (kg), secondaryOutcomes measure: Visceral adipose tisue (g), secondaryOutcomes measure: Body weight (kg), secondaryOutcomes measure: Neck circumference (cm), secondaryOutcomes measure: Chest circumference (cm), secondaryOutcomes measure: Waist circumference (cm), secondaryOutcomes measure: Mean blood pressure (mm HG), secondaryOutcomes measure: Plasma glucose (mg/dL), secondaryOutcomes measure: Change in total cholesterol (mg/dL) from baseline to post-intervention, secondaryOutcomes measure: Change in total triglycerides (mg/dL) from baseline to post-intervention, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False