Benefits of Telemedicine in CPAP Treatment

Status Completed

Clinical Trial Summary

Continuous positive airway pressure (CPAP) is the first choice of treatment for moderate to severe obstructive sleep apnea syndrome (OSAS). Although adherence is critical for achieving a good treatment effect, and early intervention if treatment problems emerge is important for achieving good adherence, information on patient compliance is usually based on assessment of the first few weeks of treatment. Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis and could therefore be an option allowing for adequate support and quick response if a patient has problems with the treatment. In addition, improving early experiences of CPAP, identifying patients in need of more intensive support could potentially improve adherence but also reduced cost of care, and increased patient satisfaction. The proposed study will recruit 200 OSAS patients starting CPAP treatment; 100 patients randomized to afterwards receiving telemonitoring in combination with telephone calls, and 100 patients randomized to receiving usual office visits. All patients will in addition answer questionnaires on sleep and health, quality of life, and patient satisfaction after the first CPAP information visit and then again after 6 months of treatment. At time of follow-up all patients will also answer questionnaires on side effects of CPAP. Health economic variables will also be measured throughout the testing period. The study will provide valuable information regarding benefits of telemonitoring in clinical work with CPAP therapy. Implementation of telemedicine-based monitoring of CPAP therapy may be an important part of increasing adherence among patients but also in the development of a more cost-effective care as it can provide clinics with increased treatment capacity and follow-up of both new and established patients. It would further improve the care for these patients who often have a lifelong treatment, which aims to reduce the risk of developing cardiovascular disease or premature death.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03202602
Study type	Observational
Source	Uppsala University
Contact
Status	Completed
Phase
Start date	August 15, 2017
Completion date	December 30, 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.