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

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 Overview

• Status: Completed
• Conditions: Sleep Apnea

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cardiac and suspected sleep disordered breathing patients

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of Cheyne Stokes respiration	over night

Secondary Outcome Measures

Outcome Measure	Time Frame
Sleep and sleep apnea parameters	over night
AH>=15	over night
plethysmography derived respiration signal	over night
Total duration of Cheyne Stokes	over night

Collaborators and Investigators

• Sponsor: WideMed LTD.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: December 1, 2008
• First Submitted That Met QC Criteria: December 1, 2008
• First Posted (ESTIMATE): December 2, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 12, 2009
• Last Update Submitted That Met QC Criteria: August 11, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: MorpheusHx002