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Recruiting

NCT Number: NCT06514482

Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location status: Recruiting

Location contact

Alejandra Roncero

CONTACT

[email protected]

677151261

Alejandra Roncero

PRINCIPAL_INVESTIGATOR

Carlos Ruiz

SUB_INVESTIGATOR

Jorge Lazaro

CONTACT

[email protected]

636920584

Marta Cristeto

SUB_INVESTIGATOR

Paula Rodriguez

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnosis

Diagnostic Test

Diagnosis

Primary outcomes

  1. Primary Outcome

    Time frame: 6 months

    Data analysis of the AHI in the respiratory polygraphy

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandra Roncero

CONTACT

[email protected]

677151261

Jorge Lazaro

CONTACT

[email protected]

636920584

Sponsors and collaborators

Lead sponsor

Hospital San Pedro de Logroño

Other

Registry information

Official study title

Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna

Acronym: HYPNOSA

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Jul 23, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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