OSANCT01918449
Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
A study testing Clinical follow up by general practitioners in primary care in people with OSA, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA
- What is being tested?
- Clinical follow up by general practitioners in primary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jun 2014
- 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 units
- 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 deprivation, regular use of hypnotic or sedative medications and 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.
- Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.
The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
- Conditions
- OSA
- Being tested
- Clinical follow up by general practitioners in primary care
- 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.
Clinical follow up by general practitioners in primary careOther
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| Sleep Unit group | No intervention | This group will have standard follow up in sleep unit at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. |
| Primary Care group | Experimental | This group will have standard follow up in primary care at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. Receives: Other: Clinical follow up by general practitioners in primary care |
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
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
Measured: Six month
Secondary outcomes (8)
Daytime sleepiness
Epworth Sleepiness Scale (ESS)
Measured: At baseline and at 6 month of follow-up
Patient satisfaction
visual analog scale (0-10)
Measured: Six month
Adverse events
Adverse events related to CPAP treatment
Measured: Six month
Quality of life
EuroQol
Measured: Baseline and at 6 month of follow up
Cost-efficacy evaluation
Qualys
Measured: Six month
Comorbidity index
Charlson index
Measured: Six month
Blood pressure
Office blood pressure
Measured: Sixt month
Lost of follow up
Percentage of patients lost during follow up
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 posted7 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionJun 2014
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundacio Catalana de Pneumologia
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbe, MD, Study director, Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)Cristina Esquinas, RN, MPH, Principal investigator, Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)Nuria Nadal, MD, Principal investigator, Primary Care. National Health Institute. Lleida (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918449
- Sponsor's protocol ID
- PI12/01499
- Status last verified
- Nov 2014
- First submitted
- 23 Jul 2013
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanchez-de-la-Torre M, Nadal N, Cortijo A, Masa JF, Duran-Cantolla J, Valls J, Serra S, Sanchez-de-la-Torre A, Gracia M, Ferrer F, Lorente I, Urgeles MC, Alonso T, Fuentes A, Armengol F, Lumbierres M, Vazquez-Polo FJ, Barbe F; Respiratory Medicine Research Group. Role of primary care in the follow-up of patients with obstructive sleep apnoea undergoing CPAP treatment: a randomised controlled trial. Thorax. 2015 Apr;70(4):346-52. doi: 10.1136/thoraxjnl-2014-206287.
PubMed 25766689
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.
- ClinicalTrials.gov ID
- NCT01918449
- Acronym / sponsor ID
- PI12/01499
- Conditions
- OSA
- Keywords
- OSA, CPAP treatment, primary care, efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundacio Catalana de Pneumologia
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Aug 2013 (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 coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Unit group | No intervention | –This group will have standard follow up in sleep unit at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. |
| Primary Care group | Experimental | Other: Clinical follow up by general practitioners in primary careThis group will have standard follow up in primary care at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. |
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 units
- Written informed consent signed.
Key exclusion criteria (6 listed)
- Previous CPAP treatment for OSA diagnosis
- Psycho-physical inability to complete questionnaires.
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and 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 |
|---|---|---|
| Clinical follow up by general practitioners in primary careThe study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment | Other | Primary Care group |
Primary outcome
Number of hours of use per day of CPAP
Time frame: Six month
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
8 secondary outcomes
Daytime sleepiness
Time frame: At baseline and at 6 month of follow-up
Patient satisfaction
Time frame: Six month
Adverse events
Time frame: Six month
Quality of life
Time frame: Baseline and at 6 month of follow up
Cost-efficacy evaluation
Time frame: Six month
Comorbidity index
Time frame: Six month
Blood pressure
Time frame: Sixt month
Lost of follow up
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 25 Nov 2014.
- Derived from this study: PubMed 25766689Sanchez-de-la-Torre M, Nadal N, Cortijo A, Masa JF, Duran-Cantolla J, Valls J, Serra S, Sanchez-de-la-Torre A, Gracia M, Ferrer F, Lorente I, Urgeles MC, Alonso T, Fuentes A, Armengol F, Lumbierres M, Vazquez-Polo FJ, Barbe F; Respiratory Medicine Research Group. Role of primary care in the follow-up of patients with obstructive sleep apnoea undergoing CPAP treatment: a randomised controlled trial. Thorax. 2015 Apr;70(4):346-52. doi: 10.1136/thoraxjnl-2014-206287.
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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 study director
Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
Cristina Esquinas, RN, MPH principal investigator
Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
Nuria Nadal, MD principal investigator
Primary Care. National Health Institute. Lleida (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical follow up by general practitioners in primary care in people with OSA, 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 6 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 25 Nov 2014. 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?
On the ClinicalTrials.gov record for NCT01918449, 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 25 Nov 2014.