NCT06370806

Lifestyle Intervention for Obstructive Sleep Apnea in Women

Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea in Women: The INTERAPNEA-Women Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
BEHAVIORAL	Weight loss and lifestyle intervention	Interdisciplinary intervention addressing weight loss and lifestyle change including nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care (i.e., CPAP)

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-04-17
• Last updated: 2024-04-17