Obstructive Sleep Apnea SyndromePrimaryNCT02141165
Home Nasal Pressure for Sleep Apnea Management in Primary Case
A study testing Diagnosis, autoCPAP, follow up. in people with Obstructive Sleep Apnea Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Diagnosis, autoCPAP, follow up.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Mar 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Snoring or apneas objectively observed during sleep by a partner;
- Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
- Age between 18 and 70 years;
- Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.
Who cannot join
- Psycho-physical incapacity to complete questionnaires;
- Documented structural or coronary heart disease uncontrolled by any medical treatment;
- Cheyne-Stokes syndrome;
- Patients subjected to uvulopalatopharyngoplasty;
- Significant nasal obstruction impeding the use of CPAP;
- Pregnancy;
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.
Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.
Read the detailed description
Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Diagnosis, autoCPAP, follow up.
- Keywords
- sleep apnea, portable monitor, primary care, cost-effectiveness, OSAS
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis, autoCPAP, follow up.Device
comparison between the efficacy of two protocol
| Study group | Role | What they receive |
|---|---|---|
| Primary. | Experimental | Diagnosis, autoCPAP, follow up. Receives: Device: Diagnosis, autoCPAP, follow up. |
| Hospital | Active comparator | Diagnosis, autoCPAP, follow up Receives: Device: Diagnosis, autoCPAP, follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale.
Measured: Before and after 6 months of follow-up
Secondary outcomes (1)
Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D.
Measured: Before and after 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionMar 2017
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 Obstructive 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Juan F. Masa, MD, Principal investigator, Hospital San Pedro de Alcántara. Cáceres. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141165
- Sponsor's protocol ID
- PI13/0238
- Acronym
- Primary
- Status last verified
- Jan 2017
- First submitted
- 17 Feb 2014
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanchez-Quiroga MA, Corral J, Gomez-de-Terreros FJ, Carmona-Bernal C, Asensio-Cruz MI, Cabello M, Martinez-Martinez MA, Egea CJ, Ordax E, Barbe F, Barca J, Masa JF; Spanish Sleep Network and Primary Care Group. Primary Care Physicians Can Comprehensively Manage Patients with Sleep Apnea. A Noninferiority Randomized Controlled Trial. Am J Respir Crit Care Med. 2018 Sep 1;198(5):648-656. doi: 10.1164/rccm.201710-2061OC.
PubMed 29664672
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
- ClinicalTrials.gov ID
- NCT02141165
- Acronym / sponsor ID
- Primary / PI13/0238
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- sleep apnea, portable monitor, primary care, cost-effectiveness, OSAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 May 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.
Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.
Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.
Detailed description
Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary. | Experimental | Device: Diagnosis, autoCPAP, follow up.Diagnosis, autoCPAP, follow up. |
| Hospital | Active comparator | Device: Diagnosis, autoCPAP, follow up.Diagnosis, autoCPAP, follow up |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Snoring or apneas objectively observed during sleep by a partner;
- Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
- Age between 18 and 70 years;
- Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.
Key exclusion criteria (7 listed)
- Psycho-physical incapacity to complete questionnaires;
- Documented structural or coronary heart disease uncontrolled by any medical treatment;
- Cheyne-Stokes syndrome;
- Patients subjected to uvulopalatopharyngoplasty;
- Significant nasal obstruction impeding the use of CPAP;
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 |
|---|---|---|
| Diagnosis, autoCPAP, follow up.comparison between the efficacy of two protocol | Device | Hospital, Primary. |
Primary outcome
Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale.
Time frame: Before and after 6 months of follow-up
1 secondary outcome
Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D.
Time frame: Before and after 6 months of follow-up
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 15 Mar 2017.
- Derived from this study: PubMed 29664672Sanchez-Quiroga MA, Corral J, Gomez-de-Terreros FJ, Carmona-Bernal C, Asensio-Cruz MI, Cabello M, Martinez-Martinez MA, Egea CJ, Ordax E, Barbe F, Barca J, Masa JF; Spanish Sleep Network and Primary Care Group. Primary Care Physicians Can Comprehensively Manage Patients with Sleep Apnea. A Noninferiority Randomized Controlled Trial. Am J Respir Crit Care Med. 2018 Sep 1;198(5):648-656. doi: 10.1164/rccm.201710-2061OC.
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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.
Juan F. Masa, MD principal investigator
Hospital San Pedro de Alcántara. Cáceres. 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 Diagnosis, autoCPAP, follow up. in people with Obstructive 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 4 inclusion and 7 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 15 Mar 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?
Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale. (time frame: Before and after 6 months of follow-up). 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 NCT02141165, 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 15 Mar 2017.