OSA
Conditions
Keywords
OSA, CPAP treatment, Primary care, Efficacy
Brief summary
The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit. METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of severe OSA that should start treatment with CPAP. Participating center is Hospital Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it was indicated the treatment with CPAP. Patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP compliance treatment in the two study groups, so that use \>= 4h/day is defined as good adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP complications, type, severity and duration; 4) To figure-out the level of take care of the CPAP machine, substitutions and complements, assistance and technical incidents; 5) Cost-effectiveness analysis.
Interventions
OTHERFollow up in Sleep Unit Group
Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
OTHERFollow up in Primary Care Group
Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
Sponsors
Spain:Health Department. Basque Government.
Linde Health Care
Hospital Universitario Araba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women over 18 years old. * Patients with OSA diagnosis performed in the sleep unit * Written informed consent signed.
Exclusion criteria
* Previous CPAP treatment for OSA diagnosis * Psycho-physical inability to complete questionnaires * Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hours of use per day of CPAP | Six month | Compare the objective CPAP compliance treatment in the two study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of clinical improvement evaluated through the Epworth Sleep Scale | At baseline and at 6 month of follow-up | Evaluate the level of clinical improvement from the start of treatment until 6 months by the changes in the Epworth Sleep Scale |
| Patient satisfaction (visual-analogical scale) | Six month | Evaluate the level of patient's satisfaction by visual-analogical scale. |
| Adverse events (number of CPAP complications) | Six month | Determine the number of CPAP complications (secondary effects). |
| Comorbidity index (Charlson index) | Six month | Charlson index |
| Blood pressure | Six month | Blood pressure measurements |
| Cost-effectiveness analysis | Six month | Cost-efficacy evaluation |
| Quality of life (EuroQOL test) | Baseline and at 6 month of follow up | Evaluate by EuroQOL test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric variables (Body mass index) | Six month | Body mass index |
Countries
Spain
Outcome results
None listed