Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Sleep study made by MicroMESAM system
micromesam system
Sleep study made by MicroMESAM system
(Active Comparator)
Sleep study made by PSG (polysomnography)
psg
Sleep study made by PSG (polysomnography)

Primary Outcomes

Measure
Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)
time frame: 3 months

Eligibility Criteria

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

Additional Information

Official title Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH).
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Basque Health Service.