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

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ClinicalTrials.gov Identifier: NCT00800397
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : August 12, 2009
Sponsor:
Information provided by:
WideMed LTD.

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.

Condition or disease
Sleep Apnea

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients
Study Start Date : December 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources




Primary Outcome Measures :
  1. Detection of Cheyne Stokes respiration [ Time Frame: over night ]

Secondary Outcome Measures :
  1. Sleep and sleep apnea parameters [ Time Frame: over night ]
  2. AH>=15 [ Time Frame: over night ]
  3. plethysmography derived respiration signal [ Time Frame: over night ]
  4. Total duration of Cheyne Stokes [ Time Frame: over night ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cardiac and suspected sleep disordered breathing patients
Criteria

Inclusion Criteria:

  1. Patient is hospitalized in the cardiology department or in the sleep lab.
  2. Patients who is willing and able to tolerate a full night Polysomnography
  3. Patient is not receiving oxygen treatment
  4. Patients is 18 years of age or above
  5. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.

Exclusion Criteria:

  1. Patients can not tolerate a full night Polysomnography.
  2. Patient is receiving oxygen.
  3. Participation in a clinical trial within the last 60 days and during the study.
  4. Life expectancy < 1 month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800397


Locations
United States, New Jersey
Morristown memorial hospital
Morristown, New Jersey, United States, 07962
Sponsors and Collaborators
WideMed LTD.

Responsible Party: Anya Eldan, WideMed LTD.
ClinicalTrials.gov Identifier: NCT00800397     History of Changes
Other Study ID Numbers: MorpheusHx002
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders