Evaluation of ApneaLink Plus Scoring Capabilities

NCT00823134 | Completed Results

• 1 other identifier: D2231-109
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Apnea, Central; Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

AL + polysomnography

OTHER

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

Device: ApneaLink Plus

Interventions

ApneaLink Plus DEVICE

Device used to evaluate for the presence of obstructive, central or mixed apneas

Also known as: AL Plus

AL + polysomnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to comprehend written and spoken German.
• Pregnant
• Patients who use of Bilevel PAP or CPAP therapy during the PSG

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen

Wangen, Baden-Wurttemberg, 88239, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Central; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Oliver Munt
• Organization: ResMed Germany Inc

oliver.munt@resmed.de

0899901

Study Officials

• Knut Joechle, PhD

  ResMed

  STUDY DIRECTOR

• Heribert Knape, MD

  Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-03

Locations

DE (1)