Sleep Apnea SyndromeNCT02517346
Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
A study testing Standard follow-up and Telemonitoring in people with Sleep Apnea Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS). 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?
- Standard follow-up and Telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Dec 2015
- 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
- Diagnosed as OSA and requiring CPAP treatment
- Written informed consent form signed.
Who cannot join
- Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, 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
The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).
Read the detailed description
Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units.
So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs.
Methods:
Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management .
Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events…).
Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database.
Patients of both 2 groups will be finally visited at 3 months at sleep unit.
- Conditions
- Sleep Apnea Syndrome
- Being tested
- Standard follow-up, Telemonitoring
- Keywords
- CPAP compliance, Telemonitoring, Standard management, Cost effectiveness
- 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.
Standard follow-upOther
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
TelemonitoringOther
Follow up by telemonitoring system during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Standard follow up-Sleep Unit | Active comparator | Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit Receives: Other: Standard follow-up |
| Telemonitoring | Experimental | Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system Receives: Other: Telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP adherence at 3 months
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
Measured: 3 months
Secondary outcomes (15)
Patients' satisfaction at 3 months
Patients will be asked to grade their satisfaction with the follow up care provided by telemonitoring /sleep unit using a questionnaire and a visual analogue scale.
Measured: 3 months
Cost effectiveness at 3 months
Costs in each group (CPAP carrying charge, number of visits and calls, number of hospital admissions) will be compared.
Measured: 3 months
Change from baseline in quality of life at 3 months
EuroQOL health questionnaire and visual analogue scale will be used.
Measured: 3 months
Fast detection of the non-adherent patient with telemonitoring
We assume that telemonitoring could quickly detect non- adherent patients.
Measured: 3 months
Change in blood pressure at 3 months
Measured: 3 months
Change in body mass index at 3 months
Measured: 3 months
Abandons at 3 months
Number of patients lost at follow up at 3 months of CPAP therapy.
Measured: 3 months
Adverse events at 3 months
Measured: 3 months
Change from baseline in snoring at 3 months
Patients will be asked about the persistence of snoring
Measured: 3 months
Change from baseline in witnessed apneas at 3 months
Patients will be asked about the persistence of witnessed apneas
Measured: 3 months
Change from baseline in nocturia at 3 months
Patients will be asked about the presence of nocturia.
Measured: 3 months
Change from baseline in daytime sleepiness at 3 months
Epworth sleepiness scale will be used.
Measured: 3 months
Changes in nocturnal gasping at 3 months
Patients will be asked about the persistence of nocturnal gasping
Measured: 3 months
Changes in sleep fragmentation at 3 months
Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia
Measured: 3 months
Presence of symptoms of restlees leg syndrome at 3 months
Patients will be asked about the presence of symptoms of restless leg syndrome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionDec 2015
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed, Asociacio Lleidatana de Respiratori
- 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
- NCT02517346
- Sponsor's protocol ID
- SEPAR2015
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Turino C, de Batlle J, Woehrle H, Mayoral A, Castro-Grattoni AL, Gomez S, Dalmases M, Sanchez-de-la-Torre M, Barbe F. Management of continuous positive airway pressure treatment compliance using telemonitoring in obstructive sleep apnoea. Eur Respir J. 2017 Feb 8;49(2):1601128. doi: 10.1183/13993003.01128-2016. Print 2017 Feb.
PubMed 28179438
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
- ClinicalTrials.gov ID
- NCT02517346
- Acronym / sponsor ID
- SEPAR2015
- Conditions
- Sleep Apnea Syndrome
- Keywords
- CPAP compliance, Telemonitoring, Standard management, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- ResMed, Asociacio Lleidatana de Respiratori
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Aug 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 purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).
Detailed description
Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units.
So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs.
Methods:
Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management .
Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events…).
Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database.
Patients of both 2 groups will be finally visited at 3 months at sleep unit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard follow up-Sleep Unit | Active comparator | Other: Standard follow-upPatients diagnosed as OSA, treated with CPAP and followed up in sleep unit |
| Telemonitoring | Experimental | Other: TelemonitoringPatients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system |
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
- Diagnosed as OSA and requiring CPAP treatment
- Written informed consent form signed.
Key exclusion criteria (8 listed)
- Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, 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 |
|---|---|---|
| Standard follow-upStandard management according to Spanish Respiratory Society guidelines in Sleep Unit. | Other | Standard follow up-Sleep Unit |
| TelemonitoringFollow up by telemonitoring system during 3 months | Other | Telemonitoring |
Primary outcome
CPAP adherence at 3 months
Time frame: 3 months
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
15 secondary outcomes
Patients' satisfaction at 3 months
Time frame: 3 months
Cost effectiveness at 3 months
Time frame: 3 months
Change from baseline in quality of life at 3 months
Time frame: 3 months
Fast detection of the non-adherent patient with telemonitoring
Time frame: 3 months
Change in blood pressure at 3 months
Time frame: 3 months
Change in body mass index at 3 months
Time frame: 3 months
Abandons at 3 months
Time frame: 3 months
Adverse events at 3 months
Time frame: 3 months
Change from baseline in snoring at 3 months
Time frame: 3 months
Change from baseline in witnessed apneas at 3 months
Time frame: 3 months
Change from baseline in nocturia at 3 months
Time frame: 3 months
Change from baseline in daytime sleepiness at 3 months
Time frame: 3 months
Changes in nocturnal gasping at 3 months
Time frame: 3 months
Changes in sleep fragmentation at 3 months
Time frame: 3 months
Presence of symptoms of restlees leg syndrome at 3 months
Time frame: 3 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 15 Apr 2016.
- Derived from this study: PubMed 28179438Turino C, de Batlle J, Woehrle H, Mayoral A, Castro-Grattoni AL, Gomez S, Dalmases M, Sanchez-de-la-Torre M, Barbe F. Management of continuous positive airway pressure treatment compliance using telemonitoring in obstructive sleep apnoea. Eur Respir J. 2017 Feb 8;49(2):1601128. doi: 10.1183/13993003.01128-2016. Print 2017 Feb.
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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 Standard follow-up and Telemonitoring 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 15 Apr 2016. 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?
CPAP adherence at 3 months (time frame: 3 months). 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 NCT02517346, 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 Apr 2016.