Clinical trial NCT00823134: Evaluation of ApneaLink Plus Scoring Capabilities
Official title: Evaluation of ApneaLink Plus Scoring Capabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Central
Sleep Apnea, Obstructive
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

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 outcomes:
measure: Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period
timeFrame: one night
measure: Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)
timeFrame: 1 night
measure: Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)
timeFrame: 1 night
measure: Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)
timeFrame: 1 night
measure: Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)
timeFrame: 1 night
measure: Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)
timeFrame: 1 night
measure: Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Wangen Im Allgäu
country: Germany
facility: Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
state: Baden-Württemberg
Study officials:
affiliation: ResMed
name: Knut Joechle, PhD
role: STUDY_DIRECTOR
affiliation: Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
name: Heribert Knape, MD
role: PRINCIPAL_INVESTIGATOR
References: