Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT03086850
Brief Summary:
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.
Study:
NCT03086850
Study Brief:
Protocol Section:
NCT03086850