Long-term Effect of the Physical Activity Promotion on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea

Randomized, Parallel and Controled Clinical Trial to Assess the Effect of the Physical Activity Promotion During 12 Months on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea

Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA).

Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and predominance of obstructive events [>80%)].

Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment.

Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up according to conventional clinical practice] or intervention group [in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (<6000 steps/day: increase by 3000 steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or increase steps).

Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ); heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP); plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily physical activity using an accelerometer.

Inclusion Criteria:

• Age from 30 to 80 years
• Diagnosis of mild-moderate obstructive sleep apnea [apnea-hypopnea index 5-30 h-1] by polysomnography or respiratory polygraphy
• Predominance of obstructive events (> 80%)
• Signature of informed consent

Exclusion Criteria:

• Previous diagnosis of chronic obstructive pulmonary disease, asthma, diffuse interstitial lung disease or chest wall disease.
• Evidence of central apneas, hypoventilation syndrome or respiratory failure
• Previous diagnosis of refractory arterial hypertension, congestive heart failure, ischemic heart disease or cerebro-vascular disease.
• Neurological or osteoarticular limitation that prevents ambulation.
• Professional drivers or occupational risk or respiratory
• Previous treatment with CPAP
• Participation in another clinical trial in the 30 days prior to randomization.