Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
- Conditions
- OSA
- Interventions
- Other: Clinical follow up by general practitioners in primary care
- Registration Number
- NCT01918449
- Lead Sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Brief Summary
The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index \>=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use \>= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- Men and women over 18 years old.
- Patients with OSA diagnosis performed in the sleep units
- Written informed consent signed.
- Previous CPAP treatment for OSA diagnosis
- Psycho-physical inability to complete questionnaires.
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
- Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
- A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
- Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary Care group Clinical follow up by general practitioners in primary care This group will have standard follow up in primary care at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
- Primary Outcome Measures
Name Time Method Number of hours of use per day of CPAP Six month Number of hours of use per day of CPAP according to the internal clock of the CPAP device
- Secondary Outcome Measures
Name Time Method Blood pressure Sixt month Office blood pressure
Lost of follow up Six month Percentage of patients lost during follow up
Daytime sleepiness At baseline and at 6 month of follow-up Epworth Sleepiness Scale (ESS)
Adverse events Six month Adverse events related to CPAP treatment
Comorbidity index Six month Charlson index
Patient satisfaction Six month visual analog scale (0-10)
Quality of life Baseline and at 6 month of follow up EuroQol
Cost-efficacy evaluation Six month Qualys
Trial Locations
- Locations (1)
Hospital santa Maria
🇪🇸Lleida, Catalonia, Spain