Sleep Apnea SyndromeGESAPNCT02234765
Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care
A study testing Primary Care-based management and Standard management in people with Sleep Apnea Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndrome
- What is being tested?
- Primary Care-based management and Standard management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years old
- Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension
- Written informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.
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."
- Conditions
- Sleep Apnea Syndrome
- Being tested
- Primary Care-based management, Standard management
- Keywords
- OSA, OSAS, Sleep apnea, Management, Primary Care, Sleep Unit, Cost-Effectiveness, ESS
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care-based managementOther
Patients will be diagnosed and follow-up in Primary Care.
Standard managementOther
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Unit | Active comparator | Patients diagnosed and followed up in the Sleep Unit. Receives: Other: Standard management |
| Primary Care | Experimental | Patients diagnosed and followed up in the Primary Care. Receives: Other: Primary Care-based management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in daytime sleepiness (ESS score) at 6 months
Epworth Sleepiness Scale (ESS)
Measured: baseline and 6 months
Cost-effectiveness at 6 months
QUALYS
Measured: 6 months
Secondary outcomes (7)
Change from baseline in quality of life
EuroQol (EQ5D)
Measured: baseline and 6 months
Satisfaction at 6 months
Visual analog scale
Measured: 6 months
CPAP compliance at 6 months
Objective data to be downloaded from the CPAP device
Measured: 6 months
Adverse events at 6 months
Adverse events / secondary effects related to CPAP compliance.
Measured: 6 months
Change from baseline in blood pressure
Office blood pressure
Measured: Baseline and 6 months
Change from baseline in body mass index
Measured: Baseline and 6 months
Lost of follow up / Abandons at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbe, MD, Principal investigator, Hospital Arnau de Vilanova. IRB Lleida. CIBERes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234765
- Sponsor's protocol ID
- PI13/02004
- Acronym
- GESAP
- Status last verified
- Feb 2017
- First submitted
- 2 Sep 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
Publications
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.
PubMed 30064993
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.
- ClinicalTrials.gov ID
- NCT02234765
- Acronym / sponsor ID
- GESAP / PI13/02004
- Conditions
- Sleep Apnea Syndrome
- Keywords
- OSA, OSAS, Sleep apnea, Management, Primary Care, Sleep Unit, Cost-Effectiveness, ESS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Unit | Active comparator | Other: Standard managementPatients diagnosed and followed up in the Sleep Unit. |
| Primary Care | Experimental | Other: Primary Care-based managementPatients diagnosed and followed up in the Primary Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 18 years old
- Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension
- Written informed consent signed
Key exclusion criteria (8 listed)
- Patients with impaired lung function (sd. overlap, obesity hypoventilation, and restrictive disorders)
- Severe heart failure
- Severe chronic pathology associated
- Psychiatric disorder
- Periodic leg movements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Care-based managementPatients will be diagnosed and follow-up in Primary Care. | Other | Primary Care |
| Standard managementStandard management according to Spanish Respiratory Society guidelines in Sleep Unit. | Other | Sleep Unit |
Primary outcome
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
7 secondary outcomes
Change from baseline in quality of life
Time frame: baseline and 6 months
Satisfaction at 6 months
Time frame: 6 months
CPAP compliance at 6 months
Time frame: 6 months
Adverse events at 6 months
Time frame: 6 months
Change from baseline in blood pressure
Time frame: Baseline and 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Derived from this study: PubMed 30064993Tarraubella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferran Barbe, MD principal investigator
Hospital Arnau de Vilanova. IRB Lleida. CIBERes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care-based management and Standard management in people with Sleep Apnea Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in daytime sleepiness (ESS score) at 6 months (time frame: baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.