Status:
UNKNOWN
ScreenOX - An Automated At-home Screening Test for Adult Sleep Apnea Using Nocturnal Oximetry
Lead Sponsor:
Hospital del Rio Hortega
Collaborating Sponsors:
OXIGEN salud
University of Valladolid
Conditions:
Sleep Apnea Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
The sleep apnea-hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent breathing cessations (apneas) or partial collapses (hypopneas) during sleep. SAHS is linked with the most i...
Detailed Description
Participants are recruited from the specialized sleep outpatient facilities of the Río Hortega University Hospital from Valladolid (Spain). All patients are referred from primary care due to moderate-...
Eligibility Criteria
Inclusion
- Men and women over 18 years old
- Subjects derived from primary care to the sleep specialized outpatient facilities showing moderate-to-high clinical suspicion of suffering from sleep apnea (daytime hypersomnolence, loud snoring, nocturnal choking and awakenings, and/or apneic events)
- Written informed consent signed
Exclusion
- Subjects under 18 years old
- Subjects not signing the informed consent
- Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and/or restless leg syndrome.
- Patients with the following chronic diseases: congestive heart failure, renal failure, neuromuscular diseases, chronic respiratory failure.
- Patients with \>50% of central apneas or the presence of Cheyne-Stokes respiration.
- Previous continuous positive airway pressure (CPAP) treatment for SAHS diagnosis
- A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions
Key Trial Info
Start Date :
January 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03295149
Start Date
January 1 2016
End Date
December 1 2018
Last Update
October 2 2017
Active Locations (1)
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1
Río Hortega University Hospital
Valladolid, Spain, 47012