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Evaluation of ApneaLink Plus Scoring Capabilities

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ClinicalTrials.gov Identifier: NCT00823134
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Condition or disease Intervention/treatment
Sleep Apnea, Central Sleep Apnea, Obstructive Device: ApneaLink Plus

Detailed Description:
  • 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

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of ApneaLink Plus Scoring Capabilities
Study Start Date : December 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009
Groups and Cohorts

Intervention Details:
    Device: ApneaLink Plus
    Device used to evaluate for the presence of obstructive, central or mixed apneas
    Other Name: AL Plus

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the sleep lab Wangen, Allgäu, Germany.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823134


Locations
Germany
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
Wangen/ Allgaeu, Baden-Württemberg, Germany, 88239
Sponsors and Collaborators
ResMed
Investigators
Study Director: Knut Joechle, PhD ResMed
Principal Investigator: Heribert Knape, MD Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
More Information

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT00823134     History of Changes
Other Study ID Numbers: D2231-109
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: January 2009

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