Obstructive Sleep Apnea Syndrome
Conditions
Keywords
sleep apnea, portable monitor, primary care, cost-effectiveness, OSAS
Brief summary
Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness. Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.
Detailed description
Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.
Interventions
DEVICEDiagnosis, autoCPAP, follow up.
comparison between the efficacy of two protocol
Sponsors
Sociedad Española de Neumología y Cirugía Torácica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Snoring or apneas objectively observed during sleep by a partner; 2. Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease; 3. Age between 18 and 70 years; 4. Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.
Exclusion criteria
1. Psycho-physical incapacity to complete questionnaires; 2. Documented structural or coronary heart disease uncontrolled by any medical treatment; 3. Cheyne-Stokes syndrome; 4. Patients subjected to uvulopalatopharyngoplasty; 5. Significant nasal obstruction impeding the use of CPAP; 6. Pregnancy; 7. Lack of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale. | Before and after 6 months of follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D. | Before and after 6 months of follow-up |
Countries
Spain
Outcome results
None listed