Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

ConditionSleep Apnea

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorHospital San Pedro de Logroño

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients who come to the sleep consultation for sleep study results for suspected OSA.

Patients older than 18 years.

Signature of the informed consent.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Diagnosis
Diagnostic test
Diagnosis

Treatment groups

1,000 Participants

are divided into 3 treatment groups

Group A: NO OSA1 intervention

Group B: OSA WHITH CPAP1 intervention

Group C: OSA WHITHOUT CPAP1 intervention

Trial outcomes

Primary outcomes

Primary Outcome

Data analysis of the AHI in the respiratory polygraphy

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital San Pedro de Logroño

Lead sponsor

Source ClinicalTrials.gov

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