Sleep Apnea Syndrome
Conditions
Keywords
Sleep apnea, Portable monitor,autoCPAP
Brief summary
Primary objectives: The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale; Secondary Objective: 1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. 2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques
Detailed description
Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will be randomized to diagnose and follow treatment based on the PR or PSG generating four groups: two treated and two untreated with CPAP. The latter did not undergo self-certification home. The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change of the scale Epworth before and after the intervention between both treatment arms using analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%. Secondary variables were analyzed by independent means differences (or nonparametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the two methods will be measured against the effectiveness of the primary endpoint using Bayesian techniques
Interventions
PROCEDUREdiagnosis and therapeutic decision
A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths
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 sleep apneas observed by partner 2. Symptoms that may be secondary to the apneas/hypopneas - concretely, an ESS ≥10 3. Age between 18 and 70 4. Absence of clinical suspicion of any other sleep pathology which could cause daytime sleepiness
Exclusion criteria
1. Psycho-physical inability to complete questionnaires 2. documented structural or coronary cardiopathy not controlled by medical treatment 3. Cheyennes-Stokes Syndrome 4. Patient has undergone an uvulopalatopharyngoplasty 5. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the efficacy of diagnosis and therapeutic decision-making evaluated using Epworth sleepiness scale as primary variable in patients managed by home RP and by PSG after six months of follow-up. | Six months |
Secondary
| Measure | Time frame |
|---|---|
| the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. | Six months |
Countries
Spain
Outcome results
None listed