CompletedInterventionalPhase 4Updated Oct 21, 2016
Evaluation of ApneaLink Plus Scoring Capabilities | NCT00823134 | Trialant
CompletedInterventionalNot ApplicableUpdated May 12, 2020
Evaluation of ApneaLink Plus Scoring Capabilities
Evaluation of ApneaLink Plus Scoring Capabilities
ClinicalTrials.gov ID
NCT00823134
Lead Sponsor
ResMedINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
23Actual
Last Update Posted
May 12, 2020Actual
Start Date
Dec 2008
Primary Completion Date
Mar 2009Actual
Completion Date
Mar 2009Actual
Official Title
Evaluation of ApneaLink Plus Scoring Capabilities
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
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
Sleep Apnea, Central
Sleep Apnea, Obstructive
ApneaLink Plus
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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
Primary Purpose
Screening
Allocation
N/A
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen