NCT01716676

Brief 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. 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. 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

October 1, 2012

First QC Date

October 29, 2012

Last Update Submit

December 8, 2014

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (3)

  • CPAP compliance

    6 months

  • Cost-effectiveness

    6 months

  • Quality of life

    6 months

Study Arms (2)

Standard CPAP follow-up

ACTIVE COMPARATOR
Other: Standard CPAP monitoring

Telemedicine CPAP follow-up

EXPERIMENTAL
Other: Telemedicine CPAP monitoring (webpage and televisit)

Interventions

Telemedicine CPAP monitoring (webpage and televisit)OTHER
Telemedicine CPAP follow-up
Standard CPAP monitoringOTHER
Standard CPAP follow-up

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of OSA;
  • years;
  • CPAP recommendation;
  • Informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26310452DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 30, 2012

Primary Completion

September 1, 2014

Last Updated

December 9, 2014

Record last verified: 2012-10

Locations

ES(1)