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Recruiting NCT06514482

Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

Observational Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnosis.
Who it may be relevant to
Registry conditions: Sleep Apnea. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna

Overview

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.

Interventions

  • Diagnostic test Diagnosis
    Diagnosis

Primary outcome measures

  • Primary Outcome [Time frame: 6 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Spain · 1 center
  • Hospital San Pedro — Logroño

Publications

  • Roncero A, Mediano O, Cano-Pumarega I, Barbe F, Lopez-Picado A, Sanchez-de-la-Torre M. HYPNOSA: Study protocol for a prospective observational cohort of patients with obstructive sleep apnea. Sleep Med. 2026 Jul 8;147:109115. doi: 10.1016/j.sleep.2026.109115. Online ahead of print. PMID 42435507

Identifiers

NCT: NCT06514482 · PI 569

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗