NCT00800397CompletedNot Applicable
Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- WideMed LTD.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Detection of Cheyne Stokes respiration
Study Overview
Brief 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 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
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Detection of Cheyne Stokes respiration
Time Frame: over night
Secondary Outcomes
- AH>=15(over night)
- Sleep and sleep apnea parameters(over night)
- plethysmography derived respiration signal(over night)
- Total duration of Cheyne Stokes(over night)
Investigators
Study Sites (1)
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