Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness (HYPNOSA)

February 12, 2026 updated by: Hospital San Pedro de Logroño

Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Recruiting
        • Hospital San Pedro
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alejandra Roncero
        • Sub-Investigator:
          • Paula Rodriguez
        • Sub-Investigator:
          • Marta Cristeto
        • Sub-Investigator:
          • Carlos Ruiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients referred to the sleep unit with suspected obstructive sleep apnea dream.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NO OSA
Control group
Diagnostic test: Diagnosis
Diagnosis
OSA WHITH CPAP
Diagnostic test: Diagnosis
Diagnosis
OSA WHITHOUT CPAP
Diagnostic test: Diagnosis
Diagnosis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Pedro de Logroño

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2022

Primary Completion (Actual)

May 30, 2025

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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