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
Universidad de Granada·ClinicalTrials.gov·behavioralNot yet recruiting
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Study focus
Disease/Condition
Obstructive Sleep Apnea
Drug/Device/Intervention
Weight loss and lifestyle intervention
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Universidad de Granada
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Dec 01, 2025
Enrollment
180 participants
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
Sleep apnoeaSleep disordersSleep disorder, unspecifiedPrimary sleep apnoea of newbornNonorganic sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06370806
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06370806 through Pure Global AI's free database. This phase not specified trial is sponsored by Universidad de Granada and is currently Not yet recruiting. The study focuses on Obstructive Sleep Apnea. Target enrollment is 180 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.