Registry of patients with sleep apnea and daytime sleepiness
Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna
This study is trying to learn more about people with sleep apnea and daytime sleepiness by tracking their health and treatment over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Pedro de Logroño Academic / other |
| Locations | 1 site (Logroño, La Rioja) |
| Trial ID | NCT06514482 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 1000 patients suspected of having obstructive sleep apnea (OSA) who are referred to a sleep unit. Participants will undergo a sleep study for diagnosis, 24-hour ambulatory blood pressure monitoring, and complete quality of life questionnaires, including the Epworth test for daytime sleepiness. The study will evaluate OSA patients at baseline and follow up at 6, 12, and 24 months to assess treatment adherence, particularly for those using CPAP. Clinical variables and biological samples will also be collected to enhance understanding of the condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are referred for sleep studies due to suspected obstructive sleep apnea.
Not a fit: Patients with other diagnosed sleep disorders or significant central apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and treatment adherence of patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown success in managing obstructive sleep apnea through similar observational approaches, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who come to the sleep consultation for sleep study results for suspected OSA. * Patients older than 18 years. * Signature of the informed consent. Exclusion Criteria: * Psycho-physical inability to complete questionnaires. * Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h/day), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome. * Patients with \> 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp). * A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions. * Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g/day in men and more than 60 gr / day in women), absence of stable habitual residence, disorientation or non-compliance history). * Any process, cardiovascular or not, that limits life expectancy to less than one year.
Where this trial is running
Logroño, La Rioja
- Hospital San Pedro — Logroño, La Rioja, Spain (Recruiting)
Study contacts
- Study coordinator: Jorge Lazaro
- Email: jlazaro@riojasalud.es
- Phone: 636920584
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.