Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

NCT ID: NCT06514482

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-28

Study Completion Date

2025-10-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NO OSA

Control group

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Diagnosis

OSA WHITH CPAP

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Diagnosis

OSA WHITHOUT CPAP

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Diagnosis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diagnosis

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital San Pedro de Logroño

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital San Pedro

Logroño, La Rioja, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jorge Lazaro

Role: CONTACT

636920584

Alejandra Roncero

Role: CONTACT

677151261

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jorge Lazaro

Role: primary

636920584

Alejandra Roncero

Role: backup

677151261

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI 569

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CPAP in SAHS Patients With Hypertension
NCT02398032 COMPLETED PHASE4