Study Results
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View full resultsBasic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2008-12-31
2009-03-31
Brief Summary
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* Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.
* Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.
* Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet
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Detailed Description
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* Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.
* Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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AL + polysomnography
Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).
ApneaLink Plus
Device used to evaluate for the presence of obstructive, central or mixed apneas
Interventions
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ApneaLink Plus
Device used to evaluate for the presence of obstructive, central or mixed apneas
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult patients who are 18 years of age or older
* No alcohol consumption 12 hrs before and during the trial period
* Normally sleep more than 3 hours per night
Exclusion Criteria
* Pregnant
* Patients who use of Bilevel PAP or CPAP therapy during the PSG
* Unsuitable for inclusion in the opinion of the investigator
18 Years
ALL
No
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Knut Joechle, PhD
Role: STUDY_DIRECTOR
ResMed
Heribert Knape, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
Locations
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Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
Wangen, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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D2231-109
Identifier Type: -
Identifier Source: org_study_id
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