Spanish Registry of Patients with Sleep Apnea and Daytime Sleepiness

Recruiting

• Conditions: Sleep Apnea
• Interventions: Diagnostic Test: Diagnosis

• Registration Number: NCT06514482
• Lead Sponsor: Hospital San Pedro de Logroño

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-28
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-05-30
• Study Completion: 2025-10-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NO OSA	Diagnosis	Control group
OSA WHITH CPAP	Diagnosis	-
OSA WHITHOUT CPAP	Diagnosis	-

Primary Outcome Measures

Name	Time	Method
Primary Outcome	6 months	Data analysis of the AHI in the respiratory polygraphy

Trial Locations

Locations (1)

Hospital San Pedro; 🇪🇸 Logroño, La Rioja, Spain