Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT01715194
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS
Sponsor:
Otto D. Schoch
Organization:
Study Overview
Official Title:
Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study
Status:
COMPLETED
Status Verified Date:
2016-07
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:
We hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control CPAP treatment during the first month improves adherence and reduces unresolved side effects of therapy.
The primary objective of an OSAS treatment program is to successfully implement indicated CPAP in the highest possible proportion of patients in order to lower the proportion of untreated OSAS in the population. On an individual basis, it has been shown that a longer duration of CPAP use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of CPAP. For our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. Cardiovascular complications are a major concern in OSAS patients. Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk. We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.
The primary objective of an OSAS treatment program is to successfully implement indicated CPAP in the highest possible proportion of patients in order to lower the proportion of untreated OSAS in the population. On an individual basis, it has been shown that a longer duration of CPAP use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of CPAP. For our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. Cardiovascular complications are a major concern in OSAS patients. Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk. We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: