Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH)
This trial is active, not recruiting.
|Condition||obstructive sleep apnea|
|Treatments||psg, micromesam system|
|Sponsor||Basque Health Service|
|Start date||March 2009|
|End date||December 2013|
|Trial size||815 participants|
|Trial identifier||NCT01347398, ApneaLink|
The diagnosis of OSASH requires expensive sleep tests that generate long waiting lists, so we need simplified and rapid diagnostic tools. The ApneaLinkTM, is a device that allows the assessment of respiratory events by measuring the flow ventilation with a nasal cannula connected to a pressure transducer.
|Intervention model||crossover assignment|
Sleep study made by MicroMESAM system
Sleep study made by PSG (polysomnography)
Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)
time frame: 3 months
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: 1. Patients 18 to 75 years of both sexes. 2. clinical suspicion of OSAH defined as subjects with breathing pauses during sleep and / or asphyxiated sounds, with or without excessive daytime sleepiness as measured by the Epworth scale and who have asked for a sleep test to rule out OSAH. 3. Informed consent signed by the patient. Exclusion Criteria: 1. Place of residence more than 100 km from the hospital. 2. inability to perform psychophysical study at home. 3. cardio-vascular disease, cerebro-vascular or respiratory or acute severe unstable as to preclude the proper conduct of studies at home and / or PSG in the laboratory. 4. Patients with chronic insomnia or recognize sleep less than six hours. 5. Patients with depression (both point 4 and 5 are the potential causes of false negatives in a PR for lack of sufficient sleep time). 6. nasal obstruction complete or nearly complete, which prevents obtaining a quality signal with MicroMESAM
|Official title||Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH).|
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