Promoting physical activity to improve sleep apnea symptoms
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
This study is testing if encouraging daily walking can help people with mild to moderate sleep apnea feel better after a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT03086850 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the long-term effects of daily physical activity promotion using a pedometer on patients with mild to moderate obstructive sleep apnea (OSA). Participants aged 30 to 80 years will be randomized into two groups: one receiving conventional treatment and the other receiving additional physical activity guidance based on their daily step counts. The primary outcome measure will be the apnea-hypopnea index (AHI) after 12 months of intervention. The study seeks to determine if increased physical activity can lead to improvements in OSA symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 80 with a diagnosis of mild to moderate obstructive sleep apnea.
Not a fit: Patients with severe respiratory conditions or those who cannot ambulate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant improvements in the management of obstructive sleep apnea through lifestyle changes.
How similar studies have performed: Previous studies have shown that lifestyle interventions, including physical activity, can positively impact sleep apnea outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madrid
- Francisco Garcia-Rio — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Francisco Garcia-Rio, MD
- Email: fgr01m@gmail.com
- Phone: +34914269802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.