Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT01796769
Status:
UNKNOWN
Last Update Posted:
2014-09-05
First Post:
2013-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study
Sponsor:
Fédération Française de Pneumologie
Organization:
Study Overview
Official Title:
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
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:
Targeted population:
Sleep apnea patients at low cardiovascular risk newly treated by CPAP
Hypothesis:
Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.
Main goal:
To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.
Sleep apnea patients at low cardiovascular risk newly treated by CPAP
Hypothesis:
Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.
Main goal:
To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.
Detailed Description:
Study procedures:
The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, CPAP compliance, side effects and residual events.
Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.
An interim analysis will be performed when 200 patients will be included.
The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, CPAP compliance, side effects and residual events.
Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.
An interim analysis will be performed when 200 patients will be included.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: