Sleep ApneaNCT00800397
Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients
An observational study of Sleep Apnea, run by WideMed LTD. at 1 site in United States.
Trial summary
Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a cardiac patient, will be found suffering from sleep breathing disorders. The medical literature also shows that there is an advantage of treating the sleep breathing disorders in addition to treating the cardiac disease or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2008
- 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: cardiac and suspected sleep disordered breathing patients
Who may be able to join
- Patient is hospitalized in the cardiology department or in the sleep lab.
- Patients who is willing and able to tolerate a full night Polysomnography
- Patient is not receiving oxygen treatment
- Patients is 18 years of age or above
- Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.
Who cannot join
- Patients can not tolerate a full night Polysomnography.
- Patient is receiving oxygen.
- Participation in a clinical trial within the last 60 days and during the study.
- Life expectancy < 1 month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown memorial hospital
Morristown, New Jersey, 07962
About this study
Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a cardiac patient, will be found suffering from sleep breathing disorders. The medical literature also shows that there is an advantage of treating the sleep breathing disorders in addition to treating the cardiac disease or evaluating the heart failure condition to provide better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac related breathing disordered.
- Conditions
- Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Cheyne Stokes respiration
Measured: over night
Secondary outcomes (4)
Sleep and sleep apnea parameters
Measured: over night
AH>=15
Measured: over night
plethysmography derived respiration signal
Measured: over night
Total duration of Cheyne Stokes
Measured: over night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionDec 2008
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WideMed LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800397
- Sponsor's protocol ID
- MorpheusHx002
- Status last verified
- Aug 2009
- First submitted
- 1 Dec 2008
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients
- ClinicalTrials.gov ID
- NCT00800397
- Acronym / sponsor ID
- MorpheusHx002
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- WideMed LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Dec 2008 (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.
Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a cardiac patient, will be found suffering from sleep breathing disorders. The medical literature also shows that there is an advantage of treating the sleep breathing disorders in addition to treating the cardiac disease or evaluating the heart failure condition to provide better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac related breathing disordered.
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
- cardiac and suspected sleep disordered breathing patients
Key inclusion criteria (5 listed)
- Patient is hospitalized in the cardiology department or in the sleep lab.
- Patients who is willing and able to tolerate a full night Polysomnography
- Patient is not receiving oxygen treatment
- Patients is 18 years of age or above
- Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.
Key exclusion criteria (4 listed)
- Patients can not tolerate a full night Polysomnography.
- Patient is receiving oxygen.
- Participation in a clinical trial within the last 60 days and during the study.
- Life expectancy < 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of Cheyne Stokes respiration
Time frame: over night
4 secondary outcomes
Sleep and sleep apnea parameters
Time frame: over night
AH>=15
Time frame: over night
plethysmography derived respiration signal
Time frame: over night
Total duration of Cheyne Stokes
Time frame: over night
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 12 Aug 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep Apnea, run by WideMed LTD. 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 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 Aug 2009. 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?
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.
What does the primary outcome measure?
Detection of Cheyne Stokes respiration (time frame: over night). 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 Aug 2009.