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Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH)

Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH).

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01347398
Enrollment
815
Registered
2011-05-04
Start date
2009-03-31
Completion date
2014-04-30
Last updated
2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Sleep apnoea, Diagnosis, Blood pressure, Body mass index, Breath analysis

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.

Interventions

PROCEDUREPSG

Sleep study made by PSG (polysomnography)

PROCEDUREMicroMESAM system

Sleep study made by MicroMESAM system

Sponsors

Basque Health Service
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026