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Clinical Trials/NCT00800397
NCT00800397CompletedNot Applicable

Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients

WideMed LTD.1 site in 1 country80 target enrollmentStarted: December 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Industry

Study Sites (1)

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