Evaluation of ApneaLink Plus Scoring Capabilities

Not Applicable

Completed

Conditions: Sleep Apnea, Obstructive
Sleep Apnea, Central

Interventions: Device: ApneaLink Plus

Registration Number: NCT00823134

Lead Sponsor: ResMed

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AL + polysomnography	ApneaLink Plus	Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).

Primary Outcome Measures

Name	Time	Method
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	one night	Apnoea is defined as a decrease in flow of ≥90% from baseline for at least 10 seconds; hypopnea is a decrease in flow ≥30% from baseline for at least 10 seconds and an oxygen desaturation of ≥4%; obstructive: breathing efforts are ongoing; central: no breathing efforts
Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)	1 night	The CAI (PSG) values and CAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)	1 night	The AHI (PSG) values and AHI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)	1 night	The AI (PSG) values and AI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)	1 night	The HI (PSG) values and HI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)	1 night	The ODI (PSG) values and ODI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)	1 night	The OAI (PSG) values and OAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.