Telemedicine in Sleep Breathing Disorders: a Multicenter Study.

Obstructive Sleep Apnea Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716676
• Other study ID #: SEPAR-PII2011
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: December 8, 2014

Study information

• Verified date: October 2012
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

N/A

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Telemedicine CPAP monitoring (webpage and televisit)

• Standard CPAP monitoring

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP compliance		6 months
Primary	Cost-effectiveness		6 months
Primary	Quality of life		6 months