Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

Launched by HOSPITAL SAN PEDRO DE LOGROÑO · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial, known as the Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness, is studying a condition called obstructive sleep apnea (OSA), which can cause breathing problems during sleep and lead to excessive daytime sleepiness. The researchers aim to gather information from 1,000 patients who come to a sleep clinic for testing. Participants will undergo a sleep study to diagnose OSA and will also have their blood pressure monitored for 24 hours. They will be asked to fill out questionnaires about their quality of life and daytime sleepiness. The trial will follow these patients over two years to see how well they manage their condition, especially if they are using a CPAP machine, a common treatment for OSA.

To be eligible for this study, participants must be over 18 years old and visit the sleep clinic due to suspected OSA. They need to provide informed consent to join. However, certain individuals will not be able to participate, such as those with other serious sleep disorders or medical issues that might interfere with the study. Throughout the trial, participants can expect regular evaluations at the start and again at 6, 12, and 24 months, helping researchers understand the long-term impact of OSA and its treatments.

Gender

ALL

Eligibility 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.