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

This study has been completed.
Sponsor:
Information provided by:
WideMed LTD.
ClinicalTrials.gov Identifier:
NCT00800397
First received: December 1, 2008
Last updated: August 11, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by WideMed LTD.:

Primary Outcome Measures:
  • Detection of Cheyne Stokes respiration [ Time Frame: over night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep and sleep apnea parameters [ Time Frame: over night ] [ Designated as safety issue: No ]
  • AH>=15 [ Time Frame: over night ] [ Designated as safety issue: No ]
  • plethysmography derived respiration signal [ Time Frame: over night ] [ Designated as safety issue: No ]
  • Total duration of Cheyne Stokes [ Time Frame: over night ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800397

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

No publications provided

Responsible Party: Anya Eldan, WideMed LTD.
ClinicalTrials.gov Identifier: NCT00800397     History of Changes
Other Study ID Numbers: MorpheusHx002
Study First Received: December 1, 2008
Last Updated: August 11, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013