Sleep ApneaARMADANCT00918502
Monitor Patients With Sleep Apnea
An observational study of Sleep Apnea, run by Corventis, Inc..
Trial summary
The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- AVIVO system
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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: sleep study
Who may be able to join
- Is female or male, 18 years of age or older
- Undergoing polysomnography for suspected sleep apnea
- Is willing to provide written informed consent and comply with study guidelines
Who cannot join
None listed.
About this study
Official title: Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study
The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography
Read the detailed description
Patients with suspected sleep disordered breathing will be monitored during polysomnography and the collected information will be used to assess patient's respiratory status.
- Conditions
- Sleep Apnea
- Being tested
- AVIVO system
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVIVO systemDevice
Non invasive external monitoring device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corventis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Imad Libbus, PhD, Study director, Corventis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918502
- Sponsor's protocol ID
- COR-2009-004
- Acronym
- ARMADA
- Status last verified
- Feb 2010
- First submitted
- 10 Jun 2009
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study
- ClinicalTrials.gov ID
- NCT00918502
- Acronym / sponsor ID
- ARMADA / COR-2009-004
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Corventis, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography
Detailed description
Patients with suspected sleep disordered breathing will be monitored during polysomnography and the collected information will be used to assess patient's respiratory status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- sleep study
Key inclusion criteria (3 listed)
- Is female or male, 18 years of age or older
- Undergoing polysomnography for suspected sleep apnea
- Is willing to provide written informed consent and comply with study guidelines
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AVIVO systemNon invasive external monitoring device | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
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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.
Imad Libbus, PhD study director
Corventis, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Corventis, Inc..
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 3 inclusion and 0 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 4 Feb 2010.