Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06514482

Acronym

HYPNOSA

Enrollment

1000

Registered

2024-07-23

Start date

2022-10-28

Completion date

2028-12-31

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

CPAP, residual sleepiness, OSA

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.

Interventions

DIAGNOSTIC_TESTDiagnosis

Diagnosis

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome	6 months	Data analysis of the AHI in the respiratory polygraphy

Countries

Spain

Contacts

CONTACTJorge Lazaro

jlazaro@riojasalud.es636920584

CONTACTAlejandra Roncero

aroncerol@riojasalud.es677151261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026