Spanish Registry of Patients with Sleep Apnea and Daytime Sleepiness

Last updated: March 11, 2025
Sponsor: Hospital San Pedro de Logroño
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Sleep Disorders

Treatment

Diagnosis

Clinical Study ID

NCT06514482
PI 569
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Patients who come to the sleep consultation for sleep study results for suspectedOSA.

  • Patients older than 18 years.

  • Signature of the informed consent.

Exclusion

Exclusion Criteria:

  • Psycho-physical inability to complete questionnaires.

  • Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleepdeprivation (less than 6h/day), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) andrestless 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 thejudgment 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 inwomen), absence of stable habitual residence, disorientation or non-compliancehistory).

  • Any process, cardiovascular or not, that limits life expectancy to less than oneyear.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Diagnosis
Phase:
Study Start date:
October 28, 2022
Estimated Completion Date:
October 28, 2025

Connect with a study center

  • Hospital San Pedro

    Logroño, La Rioja 26006
    Spain

    Active - Recruiting

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