An interventional study of Standard follow-up and Telemonitoring in Sleep Apnea Syndrome, sponsored by Sociedad Española de Neumología y Cirugía Torácica. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-15.
Sponsored by Sociedad Española de Neumología y Cirugía Torácica · Not applicable, Interventional, and Health services research
The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).
Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units.
So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs.
Methods:
Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management .
Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events...).
Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database.
Patients of both 2 groups will be finally visited at 3 months at sleep unit.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 100 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Sociedad Española de Neumología y Cirugía Torácica is the lead sponsor of 42 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit
Other: Standard follow-up
Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system
Other: Telemonitoring
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
Follow up by telemonitoring system during 3 months
CPAP adherence at 3 months
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
Time frame: 3 months
Patients' satisfaction at 3 months
Patients will be asked to grade their satisfaction with the follow up care provided by telemonitoring /sleep unit using a questionnaire and a visual analogue scale.
Time frame: 3 months
Cost effectiveness at 3 months
Costs in each group (CPAP carrying charge, number of visits and calls, number of hospital admissions) will be compared.
Time frame: 3 months
Change from baseline in quality of life at 3 months
EuroQOL health questionnaire and visual analogue scale will be used.
Time frame: 3 months
Fast detection of the non-adherent patient with telemonitoring
We assume that telemonitoring could quickly detect non- adherent patients.
Time frame: 3 months
Change in blood pressure at 3 months
Time frame: 3 months
Change in body mass index at 3 months
Time frame: 3 months
Abandons at 3 months
Number of patients lost at follow up at 3 months of CPAP therapy.
Time frame: 3 months
Adverse events at 3 months
Time frame: 3 months
Change from baseline in snoring at 3 months
Patients will be asked about the persistence of snoring
Time frame: 3 months
Change from baseline in witnessed apneas at 3 months
Patients will be asked about the persistence of witnessed apneas
Time frame: 3 months
Change from baseline in nocturia at 3 months
Patients will be asked about the presence of nocturia.
Time frame: 3 months
Change from baseline in daytime sleepiness at 3 months
Epworth sleepiness scale will be used.
Time frame: 3 months
Changes in nocturnal gasping at 3 months
Patients will be asked about the persistence of nocturnal gasping
Time frame: 3 months
Changes in sleep fragmentation at 3 months
Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia
Time frame: 3 months
Presence of symptoms of restlees leg syndrome at 3 months
Patients will be asked about the presence of symptoms of restless leg syndrome
Time frame: 3 months
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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