Evaluation of ApneaLink Plus Scoring Capabilities

Sleep Apnea, Obstructive Clinical Trial

Official title:

Evaluation of ApneaLink Plus Scoring Capabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823134
• Other study ID #: D2231-109
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

Intervention

Device:
• ApneaLink Plus
Device used to evaluate for the presence of obstructive, central or mixed apneas

Locations

Country	Name	City	State
Germany	Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen	Wangen Im Allgäu	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	one night
Primary	Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)	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.	1 night
Primary	Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)	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.	1 night
Primary	Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)	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.	1 night
Primary	Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)	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.	1 night
Primary	Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)	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.	1 night
Primary	Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)	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.	1 night