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Obstructive Sleep Apnea SyndromeNCT01716676

Telemedicine in Sleep Breathing Disorders: a Multicenter Study.

A study testing Telemedicine CPAP monitoring (webpage and televisit) and Standard CPAP monitoring in people with Obstructive Sleep Apnea Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In recent years medicine has been enhanced by the incorporation of technological innovations from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obstructive Sleep Apnea Syndrome
What is being tested?
Telemedicine CPAP monitoring (webpage and televisit) and Standard CPAP monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
1 siteSpain
Study dates
Start not givento Sep 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of OSA;
  • 18-75 years;
  • CPAP recommendation;
  • Informed consent.

Who cannot join

  • Disabling hypersomnia;
  • Pregnancy;
  • Psychiatric disorders;
  • Previous treatment with CPAP;
  • Clinical instability in the previous month;
  • Inability to use information technologies (computers and web).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036

Other trials in Spain

About this study

In recent years medicine has been enhanced by the incorporation of technological innovations from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering. One of the few exceptions in this rapid process of implementing technological advances occurs in clinical medicine, where its penetration is much less effective than in other scientific and professional fields, or even in everyday life. Attempts to tackle this problem have given rise to various initiatives in the US and Europe, including Spain.

There is a surprising paucity of telemedicine systems in clinical practice, especially with respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea (OSA), where protocols are urgently needed to alleviate this healthcare problem represented by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In others words, the growing awareness of sleep disorders, especially OSA, has not been accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these diseases.

Read more

CPAP therapy compliance is not always appropriate. Helping patients during the first two months usually determines compliance. Therefore, the development of strategies to support the patient during the first weeks is essential. However, this "collides" with reality, where it is difficult to properly care all patients because of congested sleep units. It is therefore necessary to implement new and imaginative control schemes especially at the beginning of the treatment. Patients' follow-up performed by telemedicine technology is an option that aims to substitute the face-to-face visits or at least reduce them considerably. In a future context, the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda face-to-face visits and televisits (at distance) and information which patient will provide through online questionnaires with a certain frequency.

In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients monitored by telemedicine techniques (website and televisits) is similar to that achieved by standard monitoring but more cost-effective. The study design is a multicenter randomized trial with parallel groups and blind final evaluation after CPAP treatment following two different strategies: one through conventional monitoring in the hospital (face-to-face visiting) and another by telemedicine monitoring (non-contact visiting and website).

Being tested
Telemedicine CPAP monitoring (webpage and televisit), Standard CPAP monitoring
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine CPAP monitoring (webpage and televisit)Other

  • Standard CPAP monitoringOther

Study groups in NCT01716676
Study groupRoleWhat they receive
Standard CPAP follow-upActive comparatorNot described
Receives: Other: Standard CPAP monitoring
Telemedicine CPAP follow-upExperimentalNot described
Receives: Other: Telemedicine CPAP monitoring (webpage and televisit)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CPAP compliance

    Measured: 6 months

  2. Cost-effectiveness

    Measured: 6 months

  3. Quality of life

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Primary completionSep 2014

Resources

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716676
Sponsor's protocol ID
SEPAR-PII2011
Status last verified
Oct 2012
First submitted
29 Oct 2012
Last updated
9 Dec 2014
Results posted
No

Publications

  • Isetta V, Negrin MA, Monasterio C, Masa JF, Feu N, Alvarez A, Campos-Rodriguez F, Ruiz C, Abad J, Vazquez-Polo FJ, Farre R, Galdeano M, Lloberes P, Embid C, de la Pena M, Puertas J, Dalmases M, Salord N, Corral J, Jurado B, Leon C, Egea C, Munoz A, Parra O, Cambrodi R, Martel-Escobar M, Arque M, Montserrat JM; SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax. 2015 Nov;70(11):1054-61. doi: 10.1136/thoraxjnl-2015-207032. Epub 2015 Aug 26.

    PubMed 26310452

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine CPAP monitoring (webpage and televisit) and Standard CPAP monitoring in people with Obstructive Sleep Apnea Syndrome, run by Hospital Clinic of Barcelona 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 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 9 Dec 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?

CPAP compliance (time frame: 6 months). The study lists 3 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 NCT01716676, 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 9 Dec 2014.

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