Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care (GESAP)
Primary Purpose
Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Primary Care-based management
Standard management
Sponsored by
About this trial
This is an interventional health services research trial for Sleep Apnea Syndrome focused on measuring OSA, OSAS, Sleep apnea, Management, Primary Care, Sleep Unit, Cost-Effectiveness, ESS
Eligibility Criteria
Inclusion Criteria:
- Men and women over 18 years old
- Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension
- Written informed consent signed
Exclusion Criteria:
- Patients with impaired lung function (sd. overlap, obesity hypoventilation, and restrictive disorders)
- Severe heart failure
- Severe chronic pathology associated
- Psychiatric disorder
- Periodic leg movements
- Pregnancy
- Other dyssomnias or parasomnias
- Patients already treated with CPAP
Sites / Locations
- Hospital Arnau de Vilanova-Santa María
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sleep Unit
Primary Care
Arm Description
Patients diagnosed and followed up in the Sleep Unit.
Patients diagnosed and followed up in the Primary Care.
Outcomes
Primary Outcome Measures
Change from baseline in daytime sleepiness (ESS score) at 6 months
Epworth Sleepiness Scale (ESS)
Cost-effectiveness at 6 months
QUALYS
Secondary Outcome Measures
Change from baseline in quality of life
EuroQol (EQ5D)
Satisfaction at 6 months
Visual analog scale
CPAP compliance at 6 months
Objective data to be downloaded from the CPAP device
Adverse events at 6 months
Adverse events / secondary effects related to CPAP compliance.
Change from baseline in blood pressure
Office blood pressure
Change from baseline in body mass index
Lost of follow up / Abandons at 6 months
Full Information
NCT ID
NCT02234765
First Posted
September 2, 2014
Last Updated
February 13, 2017
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT02234765
Brief Title
Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care
Acronym
GESAP
Official Title
Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Instituto de Salud Carlos III
4. Oversight
5. Study Description
Brief Summary
Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive sleepiness secondary to repeated obstruction of the upper airway during sleep and cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders. Epidemiological studies in our country have shown that OSA is a highly prevalent disease in the general population, affecting 2-4% of the adult population. The most important clinical manifestations of OSAS is a deterioration in the quality of life and an increase in cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and considering the medical complications of OSA, as well as the sociolaboral impact and its negative impact on quality of life and survival; is stated that this disease is a public health problem that requires the physician to identify patients eligible to treatment. Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health resources, comparing when the diagnosis and treatment has been established. Finally, we have a highly effective treatment using positive pressure in the upper airway (CPAP) that has been shown to be effective and cost-effective. The current situation in which all patients diagnosed with OSA and receiving different treatments are monitored and controlled by the Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our working hypothesis is: "By the coordination of actions at various levels including interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records and the use of new technologies can be achieved in AP satisfactory management of the diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both areas have a level of clinical response, satisfaction, compliance and avoidance of complications, similar to that obtained with monitoring by SU. In addition, management by AP will be more cost-effective than in the SU."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
OSA, OSAS, Sleep apnea, Management, Primary Care, Sleep Unit, Cost-Effectiveness, ESS
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep Unit
Arm Type
Active Comparator
Arm Description
Patients diagnosed and followed up in the Sleep Unit.
Arm Title
Primary Care
Arm Type
Experimental
Arm Description
Patients diagnosed and followed up in the Primary Care.
Intervention Type
Other
Intervention Name(s)
Primary Care-based management
Intervention Description
Patients will be diagnosed and follow-up in Primary Care.
Intervention Type
Other
Intervention Name(s)
Standard management
Intervention Description
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
Primary Outcome Measure Information:
Title
Change from baseline in daytime sleepiness (ESS score) at 6 months
Description
Epworth Sleepiness Scale (ESS)
Time Frame
baseline and 6 months
Title
Cost-effectiveness at 6 months
Description
QUALYS
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in quality of life
Description
EuroQol (EQ5D)
Time Frame
baseline and 6 months
Title
Satisfaction at 6 months
Description
Visual analog scale
Time Frame
6 months
Title
CPAP compliance at 6 months
Description
Objective data to be downloaded from the CPAP device
Time Frame
6 months
Title
Adverse events at 6 months
Description
Adverse events / secondary effects related to CPAP compliance.
Time Frame
6 months
Title
Change from baseline in blood pressure
Description
Office blood pressure
Time Frame
Baseline and 6 months
Title
Change from baseline in body mass index
Time Frame
Baseline and 6 months
Title
Lost of follow up / Abandons at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women over 18 years old
Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension
Written informed consent signed
Exclusion Criteria:
Patients with impaired lung function (sd. overlap, obesity hypoventilation, and restrictive disorders)
Severe heart failure
Severe chronic pathology associated
Psychiatric disorder
Periodic leg movements
Pregnancy
Other dyssomnias or parasomnias
Patients already treated with CPAP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferran Barbe, MD
Organizational Affiliation
Hospital Arnau de Vilanova. IRB Lleida. CIBERes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Arnau de Vilanova-Santa María
City
Lleida
ZIP/Postal Code
25198
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30064993
Citation
Tarraubella N, Sanchez-de-la-Torre M, Nadal N, De Batlle J, Benitez I, Cortijo A, Urgeles MC, Sanchez V, Lorente I, Lavega MM, Fuentes A, Clotet J, Llort L, Vilo L, Juni MC, Juarez A, Gracia M, Castro-Grattoni AL, Pascual L, Minguez O, Masa JF, Barbe F. Management of obstructive sleep apnoea in a primary care vs sleep unit setting: a randomised controlled trial. Thorax. 2018 Dec;73(12):1152-1160. doi: 10.1136/thoraxjnl-2017-211237. Epub 2018 Jul 31.
Results Reference
derived
Learn more about this trial
Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care
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