Sleep Apnea Syndrome Clinical Trial
Official title:
Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).
Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper
airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and
daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension ,
cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The
application of a continuous positive airways pressure (CPAP) represents the first line
therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness
and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral
performance, improves quality of life and reduces road accidents. Despite its demonstrated
efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up
could improve CPAP adherence but it would take up more work and additional costs for sleep
units.
So on that account, the investigators propose a study to demonstrate that automatic home
treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to
patient's management. Moreover, the investigators believe that telemonitoring could improve
CPAP compliance and patient's satisfaction and reduce follow-up costs.
Methods:
Prospective and randomized study during three months. Patients diagnosed as OSA in St.
Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two
groups differing in CPAP compliance monitoring and management .
Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on
how to use the device. Patients will follow the standard treatment management. All patients
will be visited at 1 month at sleep unit. Patients will be checked about progress and
adherence to therapy and any problems with their machine. Information will be downloaded
from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual
respiratory events…).
Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP
device will be provided with a modem sending daily compliance information (CPAP adherence,
CPAP pressure, mask leak, and residual respiratory events) to a web database.
Patients of both 2 groups will be finally visited at 3 months at sleep unit.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02916160 -
Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study
|
Phase 4 | |
| Active, not recruiting |
NCT00746928 -
Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects
|
N/A | |
| Terminated |
NCT00816829 -
Effect of Fenofibrate on Sleep Apnea Syndrome
|
Phase 2 | |
| Recruiting |
NCT00152711 -
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
|
N/A | |
| Completed |
NCT02482480 -
Comprehensive Management for the Treatment of Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT02408172 -
Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome
|
Phase 2/Phase 3 | |
| Terminated |
NCT01354756 -
Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population
|
N/A | |
| Terminated |
NCT01196845 -
Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome
|
N/A | |
| Completed |
NCT03116958 -
MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System
|
N/A | |
| Terminated |
NCT02649933 -
Detection of Sleep Apnea Syndrome (OSA) in Pregnant Women and Assessment of Impact of OSA on Pregnancy Course
|
N/A | |
| Completed |
NCT02789696 -
Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome
|
N/A | |
| Completed |
NCT01164631 -
Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
|
Phase 4 | |
| Completed |
NCT00317083 -
Cough Reflex and Obstructive Sleep Apnea Syndrome
|
N/A | |
| Completed |
NCT02893865 -
Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
|
N/A | |
| Completed |
NCT02234765 -
Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care
|
N/A | |
| Completed |
NCT01752556 -
Cost-effectiveness of Home Respiratory Polygraphy
|
Phase 3 | |
| Completed |
NCT00001723 -
Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
|
Phase 2 | |
| Completed |
NCT02148432 -
Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
|
N/A | |
| Completed |
NCT02657304 -
Effect of Early Education on the Observance of CPAP Treatment
|
N/A | |
| Completed |
NCT02591979 -
PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment
|