Obstructive Sleep ApneaNCT00354614
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
An observational study of Obstructive Sleep Apnea, run by ResMed at 1 site in United States.
Trial summary
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- ApneaLink Sleep Screener
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 2007
- Phase
- Observational
- 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
Study population: Pts. with suspected OSA.
Who may be able to join
- Adult subjects ( greater than 18 years of age) of either gender or any race
- Suspected sleep disordered breathing
- Untreated sleep disordered breathing
- Willingness to use AL at home within 2 days of receipt and instruction on the AL
- Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test
Who cannot join
- Any subject requiring home oxygen therapy
- Any subject currently receiving positive airway pressure therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.
Read the detailed description
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- ApneaLink Sleep Screener
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaLink Sleep ScreenerDevice
Also called AL
Device used to evaluate for the presence of OSA
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater
Measured: Simultaneous single night recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2007
- Study completionJul 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J Strollo, MD, Principal investigator, Associate Professor of medicine and Medical Director, UPMC Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354614
- Sponsor's protocol ID
- CA-09-05
- Status last verified
- Apr 2017
- First submitted
- 18 Jul 2006
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Oktay B, Rice TB, Atwood CW Jr, Passero M Jr, Gupta N, Givelber R, Drumheller OJ, Houck P, Gordon N, Strollo PJ Jr. Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea. J Clin Sleep Med. 2011 Aug 15;7(4):384-90. doi: 10.5664/JCSM.1196.
PubMed 21897775
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population
- ClinicalTrials.gov ID
- NCT00354614
- Acronym / sponsor ID
- CA-09-05
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.
Detailed description
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pts. with suspected OSA.
Key inclusion criteria (5 listed)
- Adult subjects ( greater than 18 years of age) of either gender or any race
- Suspected sleep disordered breathing
- Untreated sleep disordered breathing
- Willingness to use AL at home within 2 days of receipt and instruction on the AL
- Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test
Key exclusion criteria (2 listed)
- Any subject requiring home oxygen therapy
- Any subject currently receiving positive airway pressure therapy
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 Sleep ScreenerAlso: ALDevice used to evaluate for the presence of OSA | Device | – |
Primary outcome
Sensitivity and Specificity
Time frame: Simultaneous single night recording
Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21897775Oktay B, Rice TB, Atwood CW Jr, Passero M Jr, Gupta N, Givelber R, Drumheller OJ, Houck P, Gordon N, Strollo PJ Jr. Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea. J Clin Sleep Med. 2011 Aug 15;7(4):384-90. doi: 10.5664/JCSM.1196.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Patrick J Strollo, MD principal investigator
Associate Professor of medicine and Medical Director, UPMC Sleep Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by ResMed at 1 site in United States.
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 5 inclusion and 2 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 28 Jun 2017. 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 United States. 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 28 Jun 2017). 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?
Sensitivity and Specificity (time frame: Simultaneous single night recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00354614, which also lists 1 linked publication.
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 28 Jun 2017.