Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

NCT06514482 | Recruiting DMC

• 1 other identifier: PI 569
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

CPAP, residual sleepiness, OSA

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Data analysis of the AHI in the respiratory polygraphy

  6 months

Study Arms (3)

NO OSA

Control group

Diagnostic Test: Diagnosis

OSA WHITH CPAP

Diagnostic Test: Diagnosis

OSA WHITHOUT CPAP

Diagnostic Test: Diagnosis

Interventions

Diagnosis DIAGNOSTIC_TEST

Diagnosis

NO OSA; OSA WHITH CPAP; OSA WHITHOUT CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients who come to the sleep consultation for sleep study results for suspected OSA.
• Patients older than 18 years.
• Signature of the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Pedro de Logroño: lead

Study Sites (1)

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Microcephaly, Primary Autosomal Recessive, 6; Sleep Apnea, Obstructive

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Jorge Lazaro

CONTACT

636920584; jlazaro@riojasalud.es

Alejandra Roncero

CONTACT

677151261; aroncerol@riojasalud.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: July 23, 2024
• Study Start: October 28, 2022
• Primary Completion: May 30, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 17, 2026

Record last verified: 2025-03

Locations

ES (1)