Clinical trial NCT01347398: Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH)
Official title: Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep apnoea
Diagnosis
Blood pressure
Body mass index
Breath analysis
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2011-05-04
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.