Lifestyle Intervention for Obstructive Sleep Apnea in Women - Trial NCT06370806

Timeline & Enrollment

Primary Outcome

Apnoea-hypopnoea index (AHI)

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.

ICD-10 Classifications