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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Basque Health Service.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: May 4, 2011
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Basque Health Service
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.

Condition Intervention
Obstructive Sleep Apnea Procedure: PSG Procedure: MicroMESAM system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH).

Resource links provided by NLM:

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK) [ Time Frame: 3 months ]

Estimated Enrollment: 815
Study Start Date: March 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MicroMESAM
Sleep study made by MicroMESAM system
Procedure: MicroMESAM system
Sleep study made by MicroMESAM system
Active Comparator: PSG
Sleep study made by PSG (polysomnography)
Procedure: PSG
Sleep study made by PSG (polysomnography)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Txagorritxu (Joaquín Duran Cantolla), Basque Health Service
ClinicalTrials.gov Identifier: NCT01347398     History of Changes
Other Study ID Numbers: ApneaLink
First Submitted: April 18, 2011
First Posted: May 4, 2011
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Basque Health Service:
Sleep apnoea
Blood pressure
Body mass index
Breath analysis

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases