Sleep Apnea, CentralNCT00823134
Evaluation of ApneaLink Plus Scoring Capabilities
A study testing ApneaLink Plus in people with Sleep Apnea, Central and Sleep Apnea, Obstructive, run by ResMed at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Central, Sleep Apnea, Obstructive
- What is being tested?
- ApneaLink Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
Wangen, Baden-Wurttemberg, 88239
About this study
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
Read the 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
- Conditions
- Sleep Apnea, Central, Sleep Apnea, Obstructive
- Being tested
- ApneaLink Plus
- Medical subject headings
- Sleep Apnea, Central, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaLink PlusDevice
Also called AL Plus
Device used to evaluate for the presence of obstructive, central or mixed apneas
| Study group | Role | What they receive |
|---|---|---|
| AL + polysomnography | Other | Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central). Receives: Device: ApneaLink Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea, CentralStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Knut Joechle, PhD, Study director, ResMedHeribert Knape, MD, Principal investigator, Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823134
- Sponsor's protocol ID
- D2231-109
- Status last verified
- Mar 2020
- First submitted
- 13 Jan 2009
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ApneaLink Plus Scoring Capabilities
- ClinicalTrials.gov ID
- NCT00823134
- Acronym / sponsor ID
- D2231-109
- Conditions
- Sleep Apnea, Central, Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL + polysomnography | Other | Device: ApneaLink PlusParticipant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApneaLink PlusAlso: AL PlusDevice used to evaluate for the presence of obstructive, central or mixed apneas | Device | AL + polysomnography |
Primary outcome
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
Time frame: 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 Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)
Time frame: 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)
Time frame: 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 Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)
Time frame: 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.
Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)
Time frame: 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-Index (HI) (PSG) - HI (AL)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Joechle, PhD study director
ResMed
Heribert Knape, MD principal investigator
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ApneaLink Plus in people with Sleep Apnea, Central and Sleep Apnea, Obstructive, run by ResMed at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: one night). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.