An interventional study of Diagnosis and monitoring of OSA patients in Obstructive Sleep Apnea, sponsored by Hospital Universitario San Juan de Alicante. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-07-27.
Sponsored by Hospital Universitario San Juan de Alicante · Not applicable, Interventional, and Supportive care
The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.
The aim of our study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.
Detailed Description: We conducted a prospective comparative study. Patients referred for suspected OSAS were evaluated. In the first visit patients completed four questionnaires: Epworth sleepiness scale, Impact Functional Illness Questionnaire (FOSQ), activity questionnaire and symptom questionnaire.
Patients were randomised to three groups:
Following the diagnostic test (PSG or RP), patients were visited by the Pulmonologist, who identified the need for CPAP treatment.
Patients were evaluated after 1,3 and 6 months of CPAP treatment. In all follow-up visits compliance was evaluated by objective methods and questionnaires described above were filled in.
In domiciliary group, phone calls or hospital appointments were made if low compliance was detected or if some problem with treatment was detected.
Instrumentation.
Follow-up visits and assessment of compliance:
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 66 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Hospital Universitario San Juan de Alicante is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with high probability of OSA, defined by two or more of :
Exclusion Criteria:
In this group OSA diagnosis was performed at patient's home by mean of non-attended RP. All follow-up visits were conducted by a trained nurse in patient's home.
Other: Diagnosis and monitoring of OSA patients
In this group diagnosis was made by in-hospital PSG. Follow-up was performed at hospital by a specialist Physician
Other: Diagnosis and monitoring of OSA patients
In this group diagnosis was made by home RP, and follow-up at hospital
Other: Diagnosis and monitoring of OSA patients
The difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home)
Also known as: Domiciliary group: group A, Hospital group: group B, Mixed Group: groupC
Differences in compliance among the three different strategies, measured by CPAP hours of use
Time frame: six months follow-up
costs of the three different strategies, including number of visits and phone calls that were necessary to improve compliance and additional diagnostic tests.
Time frame: six months follow-up
This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Hospital Universitario San Juan de Alicante