OSACPAP-SU-MAPNCT02459548
Continuous Positive Airway Pressure (CPAP) for Primary Care
A study testing Follow up in Sleep Unit Group and Follow up in Primary Care Group in people with OSA, run by Hospital Universitario Araba at 1 site in Spain.
Trial summary
The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA
- What is being tested?
- Follow up in Sleep Unit Group and Follow up in Primary Care Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- Feb 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.
- Patients with OSA diagnosis performed in the sleep unit
- Written informed consent signed.
Who cannot join
- Previous CPAP treatment for OSA diagnosis
- Psycho-physical inability to complete questionnaires
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad restless leg syndrome
- Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
- A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Programme of Treatment and Follow-Up for Obstructive Sleep Apnea (OSA) Patients to be Applied by General Practitioners (GPs). Collaborative Network System Between GPs, CPAP Provider Enterprise and Sleep Specialists
The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit.
METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of severe OSA that should start treatment with CPAP. Participating center is Hospital Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it was indicated the treatment with CPAP.
Patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP compliance treatment in the two study groups, so that use >= 4h/day is defined as good adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP complications, type, severity and duration; 4) To figure-out the level of take care of the CPAP machine, substitutions and complements, assistance and technical incidents; 5) Cost-effectiveness analysis.
- Conditions
- OSA
- Being tested
- Follow up in Sleep Unit Group, Follow up in Primary Care Group
- Keywords
- OSA, CPAP treatment, Primary care, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up in Sleep Unit GroupOther
Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
Follow up in Primary Care GroupOther
Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Group | Experimental | This group will be follow up in Primary Care at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires. Receives: Other: Follow up in Primary Care Group |
| Sleep Unit Group | Other | This group will be follow up in Sleep unit at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires. Receives: Other: Follow up in Sleep Unit Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hours of use per day of CPAP
Compare the objective CPAP compliance treatment in the two study groups.
Measured: Six month
Secondary outcomes (7)
Level of clinical improvement evaluated through the Epworth Sleep Scale
Evaluate the level of clinical improvement from the start of treatment until 6 months by the changes in the Epworth Sleep Scale
Measured: At baseline and at 6 month of follow-up
Patient satisfaction (visual-analogical scale)
Evaluate the level of patient's satisfaction by visual-analogical scale.
Measured: Six month
Adverse events (number of CPAP complications)
Determine the number of CPAP complications (secondary effects).
Measured: Six month
Quality of life (EuroQOL test)
Evaluate by EuroQOL test
Measured: Baseline and at 6 month of follow up
Comorbidity index (Charlson index)
Charlson index
Measured: Six month
Blood pressure
Blood pressure measurements
Measured: Six month
Cost-effectiveness analysis
Cost-efficacy evaluation
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startFeb 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.
- Other trials for OSAStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Araba
- Sponsor type
- University, hospital or other
- Collaborators
- Basque Government Department of Public Health, Linde Health Care
- Responsible party
- Principal investigator, Joaquin Duran-Cantolla, MD, Hospital Universitario Araba
- Investigators
- Joaquin Duran-Cantolla, MD, Principal investigator, Hospital Universitario Araba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459548
- Sponsor's protocol ID
- 2010111082
- Acronym
- CPAP-SU-MAP
- Status last verified
- Dec 2018
- First submitted
- 1 Apr 2015
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Programme of Treatment and Follow-Up for Obstructive Sleep Apnea (OSA) Patients to be Applied by General Practitioners (GPs). Collaborative Network System Between GPs, CPAP Provider Enterprise and Sleep Specialists
- ClinicalTrials.gov ID
- NCT02459548
- Acronym / sponsor ID
- CPAP-SU-MAP / 2010111082
- Conditions
- OSA
- Keywords
- OSA, CPAP treatment, Primary care, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hospital Universitario ArabaUniversity, hospital or other
- Collaborators
- Basque Government Department of Public Health, Linde Health Care
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Jun 2015 (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.
The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit.
METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of severe OSA that should start treatment with CPAP. Participating center is Hospital Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it was indicated the treatment with CPAP.
Patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP compliance treatment in the two study groups, so that use >= 4h/day is defined as good adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP complications, type, severity and duration; 4) To figure-out the level of take care of the CPAP machine, substitutions and complements, assistance and technical incidents; 5) Cost-effectiveness analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Care Group | Experimental | Other: Follow up in Primary Care GroupThis group will be follow up in Primary Care at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires. |
| Sleep Unit Group | Other | Other: Follow up in Sleep Unit GroupThis group will be follow up in Sleep unit at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires. |
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.
- Patients with OSA diagnosis performed in the sleep unit
- Written informed consent signed.
Key exclusion criteria (5 listed)
- Previous CPAP treatment for OSA diagnosis
- Psycho-physical inability to complete questionnaires
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad restless leg syndrome
- Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
- A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
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 |
|---|---|---|
| Follow up in Sleep Unit GroupCompare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit. | Other | Sleep Unit Group |
| Follow up in Primary Care GroupCompare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit. | Other | Primary Care Group |
Primary outcome
Number of hours of use per day of CPAP
Time frame: Six month
Compare the objective CPAP compliance treatment in the two study groups.
7 secondary outcomes
Level of clinical improvement evaluated through the Epworth Sleep Scale
Time frame: At baseline and at 6 month of follow-up
Patient satisfaction (visual-analogical scale)
Time frame: Six month
Adverse events (number of CPAP complications)
Time frame: Six month
Quality of life (EuroQOL test)
Time frame: Baseline and at 6 month of follow up
Comorbidity index (Charlson index)
Time frame: Six month
Blood pressure
Time frame: Six month
Cost-effectiveness analysis
Time frame: Six month
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 4 Dec 2018.
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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.
Joaquin Duran-Cantolla, MD principal investigator
Hospital Universitario Araba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up in Sleep Unit Group and Follow up in Primary Care Group in people with OSA, run by Hospital Universitario Araba 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 5 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 4 Dec 2018. 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?
Number of hours of use per day of CPAP (time frame: Six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2018.