Telemedicine in Sleep Breathing Disorders: a Multicenter Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01716676
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : December 9, 2014
Information provided by:
Hospital Clinic of Barcelona

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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Other: Telemedicine CPAP monitoring (webpage and televisit) Other: Standard CPAP monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Standard CPAP follow-up Other: Standard CPAP monitoring
Experimental: Telemedicine CPAP follow-up Other: Telemedicine CPAP monitoring (webpage and televisit)

Primary Outcome Measures :
  1. CPAP compliance [ Time Frame: 6 months ]
  2. Cost-effectiveness [ Time Frame: 6 months ]
  3. Quality of life [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01716676

Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01716676     History of Changes
Other Study ID Numbers: SEPAR-PII2011
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: October 2012

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