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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT01347398
First received: April 18, 2011
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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: 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 ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hospital Txagorritxu (Joaquín Duran Cantolla), Basque Health Service
ClinicalTrials.gov Identifier: NCT01347398     History of Changes
Other Study ID Numbers: ApneaLink
Study First Received: April 18, 2011
Last Updated: February 6, 2013
Health Authority: Spain: Ethics Committee

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
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014