Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370806
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-11
Brief Title:
Lifestyle Intervention for Obstructive Sleep Apnea in Women
Sponsor:
Universidad de Granada
Organization:
Universidad de Granada
Study Overview
Official Title:
Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea in Women The INTERAPNEA-Women Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERAPNEA-W
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 kgm2 and severe to moderate OSA randomly assigned to usual care ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None