NCT06514482 Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness
| NCT ID | NCT06514482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital San Pedro de Logroño |
| Condition | Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-10-28 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-10-28 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out. OSA patients will be evaluated at baseline, 6, 12, and 24 months.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06514482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06514482 currently recruiting?
Yes, NCT06514482 is actively recruiting participants. Contact the research team at jlazaro@riojasalud.es for enrollment information.
Where is the NCT06514482 trial being conducted?
This trial is being conducted at Logroño, Spain.
Who is sponsoring the NCT06514482 clinical trial?
NCT06514482 is sponsored by Hospital San Pedro de Logroño. The trial plans to enroll 1,000 participants.