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:
Basque Health Service
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT01347398
First received: April 18, 2011
Last updated: February 6, 2013
Last verified: February 2013
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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:
- Patients 18 to 75 years of both sexes.
- 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.
- Informed consent signed by the patient.
Exclusion Criteria:
- Place of residence more than 100 km from the hospital.
- inability to perform psychophysical study at home.
- 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.
- Patients with chronic insomnia or recognize sleep less than six hours.
- Patients with depression (both point 4 and 5 are the potential causes of false negatives in a PR for lack of sufficient sleep time).
- nasal obstruction complete or nearly complete, which prevents obtaining a quality signal with MicroMESAM
Contacts and Locations
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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013