Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH)
NCT ID: NCT01347398
Last Updated: 2013-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
815 participants
INTERVENTIONAL
2009-03-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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MicroMESAM
Sleep study made by MicroMESAM system
MicroMESAM system
Sleep study made by MicroMESAM system
PSG
Sleep study made by PSG (polysomnography)
PSG
Sleep study made by PSG (polysomnography)
Interventions
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PSG
Sleep study made by PSG (polysomnography)
MicroMESAM system
Sleep study made by MicroMESAM system
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Basque Health Service
OTHER_GOV
Responsible Party
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Basque Health Service
References
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Masa JF, Duran-Cantolla J, Capote F, Cabello M, Abad J, Garcia-Rio F, Ferrer A, Fortuna AM, Gonzalez-Mangado N, de la Pena M, Aizpuru F, Barbe F, Montserrat JM; Spanish Sleep Network. Efficacy of home single-channel nasal pressure for recommending continuous positive airway pressure treatment in sleep apnea. Sleep. 2015 Jan 1;38(1):13-21. doi: 10.5665/sleep.4316.
Masa JF, Duran-Cantolla J, Capote F, Cabello M, Abad J, Garcia-Rio F, Ferrer A, Mayos M, Gonzalez-Mangado N, de la Pena M, Aizpuru F, Barbe F, Montserrat JM; Spanish Sleep Network; Larrateguy LD, de Castro JR, Garcia-Ledesma E, Utrabo I, Corral J, Martinez-Null C, Egea C, Cancelo L, Garcia-Diaz E, Carmona-Bernal C, Sanchez-Armengol A, Fortuna AM, Miralda RM, Troncoso MF, Monica G, Martinez-Martinez M, Cantalejo O, Pierola J, Vigil L, Embid C, Del Mar Centelles M, Prieto TR, Rojo B, Vanesa L. Effectiveness of home single-channel nasal pressure for sleep apnea diagnosis. Sleep. 2014 Dec 1;37(12):1953-61. doi: 10.5665/sleep.4248.
Other Identifiers
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ApneaLink
Identifier Type: -
Identifier Source: org_study_id
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