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
  Purpose

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 Intervention
Sleep Apnea, Central
Sleep Apnea, Obstructive
Device: ApneaLink Plus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of ApneaLink Plus Scoring Capabilities

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: December 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ApneaLink Plus
    Device used to evaluate for the presence of obstructive, central or mixed apneas
    Other Name: AL 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT00823134     History of Changes
Other Study ID Numbers: D2231-109
Study First Received: January 13, 2009
Last Updated: October 31, 2011
Health Authority: United States: Institutional Review Board

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014