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

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ClinicalTrials.gov Identifier: NCT01347398
Recruitment Status : Unknown
Verified February 2013 by Basque Health Service.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2011
Last Update Posted : February 7, 2013
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Procedure: PSG Procedure: MicroMESAM system

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 815 participants
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).
Study Start Date : March 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

Eligibility Criteria

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
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
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 Posted: May 4, 2011    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

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

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