Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care (GESAP)
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|ClinicalTrials.gov Identifier: NCT02234765|
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : February 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndrome||Other: Primary Care-based management Other: Standard management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||May 2016|
Active Comparator: Sleep Unit
Patients diagnosed and followed up in the Sleep Unit.
Other: Standard management
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
Experimental: Primary Care
Patients diagnosed and followed up in the Primary Care.
Other: Primary Care-based management
Patients will be diagnosed and follow-up in Primary Care.
- Change from baseline in daytime sleepiness (ESS score) at 6 months [ Time Frame: baseline and 6 months ]Epworth Sleepiness Scale (ESS)
- Cost-effectiveness at 6 months [ Time Frame: 6 months ]QUALYS
- Change from baseline in quality of life [ Time Frame: baseline and 6 months ]EuroQol (EQ5D)
- Satisfaction at 6 months [ Time Frame: 6 months ]Visual analog scale
- CPAP compliance at 6 months [ Time Frame: 6 months ]Objective data to be downloaded from the CPAP device
- Adverse events at 6 months [ Time Frame: 6 months ]Adverse events / secondary effects related to CPAP compliance.
- Change from baseline in blood pressure [ Time Frame: Baseline and 6 months ]Office blood pressure
- Change from baseline in body mass index [ Time Frame: Baseline and 6 months ]
- Lost of follow up / Abandons at 6 months [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234765
|Hospital Arnau de Vilanova-Santa María|
|Lleida, Spain, 25198|
|Principal Investigator:||Ferran Barbe, MD||Hospital Arnau de Vilanova. IRB Lleida. CIBERes|