Telemedicine in Sleep Breathing Disorders: a Multicenter Study.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01716676
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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).


Condition Intervention
Obstructive Sleep Apnea Syndrome
Other: Telemedicine CPAP monitoring (webpage and televisit)
Other: Standard CPAP monitoring

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Arms Assigned Interventions
Active Comparator: Standard CPAP follow-up Other: Standard CPAP monitoring
Experimental: Telemedicine CPAP follow-up Other: Telemedicine CPAP monitoring (webpage and televisit)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Disabling hypersomnia;
  • Pregnancy;
  • Psychiatric disorders;
  • Previous treatment with CPAP;
  • Clinical instability in the previous month;
  • Inability to use information technologies (computers and web).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716676

Contacts
Contact: Josep MI Montserrat, MD PhD +3493227 ext 5746 jmmontserrat@ub.edu

Locations
Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Josep M Montserrat, MD PhD    +3493227 ext 5746    jmmontserrat@ub.edu   
Principal Investigator: Josep M Montserrat, MD PhD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01716676     History of Changes
Other Study ID Numbers: SEPAR-PII2011
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014