ClinicalTrials.Veeva

Menu

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

B

Basque Health Service

Status

Unknown

Conditions

Obstructive Sleep Apnea

Treatments

Procedure: PSG
Procedure: MicroMESAM system

Study type

Interventional

Funder types

Other

Identifiers

NCT01347398
ApneaLink

Details and patient eligibility

About

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.

Enrollment

815 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

815 participants in 2 patient groups

MicroMESAM
Experimental group
Description:
Sleep study made by MicroMESAM system
Treatment:
Procedure: MicroMESAM system
PSG
Active Comparator group
Description:
Sleep study made by PSG (polysomnography)
Treatment:
Procedure: PSG

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems