Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea in Women: The INTERAPNEA-Women Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universidad de Granada
- Enrollment
- 180
- Primary Endpoint
- Apnoea-hypopnoea index (AHI)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previous clinical diagnosis of moderate/severe OSA (AHI > 15)
- •Female patients aged between 18-65 years.
- •Body mass index > 25 kg/m
- •Use of CPAP.
- •Motivation to participate in the study.
- •Signed informed consent form.
Exclusion Criteria
- •Sleep disorder other than OSA.
- •Clinically significant psychiatric, neurological, or medical disorders other than OSA.
- •Use of prescription drugs or clinically significant drugs affecting sleep.
Outcomes
Primary Outcomes
Apnoea-hypopnoea index (AHI)
Time Frame: Post-intervention (2 months)
Change in apnea (airflow reduction greater than or equal to 90%) and hypopnea (airflow reduction greater than or equal to 30%) episodes per hour of sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Secondary Outcomes
- Light sleep (N1 and N2 stages)(Post-intervention (2 months))
- Chest circumference (cm)(Post-intervention (2 months))
- Plasma glucose (mg/dL)(Post-intervention (2 months))
- Body weight (kg)(Post-intervention (2 months))
- Sleep efficiency(Post-intervention (2 months))
- Deep sleep (N3 stage)(Post-intervention (2 months))
- Excessive daytime sleepiness (EDS)(Post-intervention (2 months))
- Sleep Quality(Post-intervention (2 months))
- Visceral adipose tisue (g)(Post-intervention (2 months))
- Waist circumference (cm)(Post-intervention (2 months))
- Oxygen saturation (SaO2) nadir(Post-intervention (2 months))
- Fat mass (kg)(Post-intervention (2 months))
- Mean blood pressure (mm HG)(Post-intervention (2 months))
- Oxygen desaturation index (ODI)(Post-intervention (2 months))
- Oxygen saturation (SaO2) mean(Post-intervention (2 months))
- Rapid eye movement (REM) sleep(Post-intervention (2 months))
- Wake After Sleep Onset (WASO)(Post-intervention (2 months))
- Neck circumference (cm)(Post-intervention (2 months))
- Change in total cholesterol (mg/dL) from baseline to post-intervention(Post-intervention (2 months))
- Change in total triglycerides (mg/dL) from baseline to post-intervention(Post-intervention (2 months))
Investigators
Almudena Carneiro Barrera
Principal Investigator
Universidad Loyola Andalucia