Telemedicine in Sleep Breathing Disorders: a Multicenter Study.
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemedicine CPAP monitoring (webpage and televisit)
Standard CPAP monitoring
Sponsored by
About this trial
This is an interventional trial for Obstructive Sleep Apnea Syndrome
Eligibility 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).
Sites / Locations
- Hospital Clínic de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard CPAP follow-up
Telemedicine CPAP follow-up
Arm Description
Outcomes
Primary Outcome Measures
CPAP compliance
Cost-effectiveness
Quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT01716676
First Posted
October 29, 2012
Last Updated
December 8, 2014
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01716676
Brief Title
Telemedicine in Sleep Breathing Disorders: a Multicenter Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Standard CPAP follow-up
Arm Type
Active Comparator
Arm Title
Telemedicine CPAP follow-up
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Telemedicine CPAP monitoring (webpage and televisit)
Intervention Type
Other
Intervention Name(s)
Standard CPAP monitoring
Primary Outcome Measure Information:
Title
CPAP compliance
Time Frame
6 months
Title
Cost-effectiveness
Time Frame
6 months
Title
Quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
26310452
Citation
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.
Results Reference
derived
Learn more about this trial
Telemedicine in Sleep Breathing Disorders: a Multicenter Study.
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