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Evaluation of ApneaLink Plus Scoring Capabilities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT00823134
First received: January 13, 2009
Last updated: October 31, 2011
Last verified: January 2009

January 13, 2009
October 31, 2011
December 2008
March 2009   (final data collection date for primary outcome measure)
Assessment of the Correlation Coefficient (Number of apneas (all apneas, obstructive, mixed, central) and Number of hypopneas) between ApneaLink Plus and a PSG system within the same evaluation period [ Time Frame: one night ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00823134 on ClinicalTrials.gov Archive Site
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Evaluation of ApneaLink Plus Scoring Capabilities
Evaluation of ApneaLink Plus Scoring Capabilities

The purpose of this study is to investigate the following topics:

  • 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
  • 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
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients will be recruited from the sleep lab Wangen, Allgäu, Germany.

  • Sleep Apnea, Central
  • Sleep Apnea, Obstructive
Device: ApneaLink Plus
Device used to evaluate for the presence of obstructive, central or mixed apneas
Other Name: AL Plus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing to give written informed consent
  • 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:

  • Unable to comprehend written and spoken German.
  • Pregnant
  • Patients who use of Bilevel PAP or CPAP therapy during the PSG
  • Unsuitable for inclusion in the opinion of the investigator
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00823134
D2231-109
No
ResMed
ResMed
Not Provided
Study Director: Knut Joechle, PhD ResMed
Principal Investigator: Heribert Knape, MD Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
ResMed
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP