OSA
Conditions
Keywords
OSA, CPAP treatment, primary care, efficacy
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.
Interventions
OTHERClinical follow up by general practitioners in primary care
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
Sponsors
Instituto de Salud Carlos III
Fundacio Catalana de Pneumologia
Sociedad Española de Neumología y Cirugía Torácica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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 units * 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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Daytime sleepiness | At baseline and at 6 month of follow-up | Epworth Sleepiness Scale (ESS) |
| Patient satisfaction | Six month | visual analog scale (0-10) |
| Adverse events | Six month | Adverse events related to CPAP treatment |
| Quality of life | Baseline and at 6 month of follow up | EuroQol |
| Comorbidity index | Six month | Charlson index |
| Blood pressure | Sixt month | Office blood pressure |
| Lost of follow up | Six month | Percentage of patients lost during follow up |
| Cost-efficacy evaluation | Six month | Qualys |
Other
| Measure | Time frame |
|---|---|
| Body mass index | Six month |
Countries
Spain
Outcome results
None listed