Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314477
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-25
Brief Title:
Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma The ASTHMA-SLEEP Trial
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea The ASTHMA-SLEEP Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea OSA
Detailed Description:
Background The prevalence of obstructive sleep apnea OSA is high in patients with severe uncontrolled asthma and can worsen asthma control Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma Nevertheless there are no studies in patients with severe uncontrolled asthma
Primary objective To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and AOS
Methodology Multicenter prospective randomized controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness Epworth sleepiness scale score 10 All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index AHI 15hour will be randomized in a 11 ratio to receive conservative treatment or conservative treatment plus CPAP Monitoring will be carried out during12 months Patients will be evaluated at inclusion at 1 month 6 and 12 months
Primary objective To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and AOS
Methodology Multicenter prospective randomized controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness Epworth sleepiness scale score 10 All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index AHI 15hour will be randomized in a 11 ratio to receive conservative treatment or conservative treatment plus CPAP Monitoring will be carried out during12 months Patients will be evaluated at inclusion at 1 month 6 and 12 months
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