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Evaluation of ApneaLink Plus Scoring Capabilities

Primary Purpose

Sleep Apnea, Central, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ApneaLink Plus
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Apnea, Central

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AL + polysomnography

Arm Description

Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2009
Last Updated
April 29, 2020
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT00823134
Brief Title
Evaluation of ApneaLink Plus Scoring Capabilities
Official Title
Evaluation of ApneaLink Plus Scoring Capabilities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Central, Sleep Apnea, Obstructive

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AL + polysomnography
Arm Type
Other
Arm Description
Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).
Intervention Type
Device
Intervention Name(s)
ApneaLink Plus
Other Intervention Name(s)
AL Plus
Intervention Description
Device used to evaluate for the presence of obstructive, central or mixed apneas
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
one night
Title
Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)
Description
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.
Time Frame
1 night
Title
Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)
Description
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.
Time Frame
1 night
Title
Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)
Description
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.
Time Frame
1 night
Title
Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)
Description
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.
Time Frame
1 night
Title
Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)
Description
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.
Time Frame
1 night
Title
Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)
Description
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.
Time Frame
1 night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Joechle, PhD
Organizational Affiliation
ResMed
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heribert Knape, MD
Organizational Affiliation
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
City
Wangen Im Allgäu
State/Province
Baden-Württemberg
ZIP/Postal Code
88239
Country
Germany

12. IPD Sharing Statement

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Evaluation of ApneaLink Plus Scoring Capabilities

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