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OpenTrials
Completed

NCT Number: NCT00800397

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Morristown memorial hospital

Morristown, New Jersey, 07962, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Detection of Cheyne Stokes respiration

    Time frame: over night

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

WideMed LTD.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 2, 2008
Registry last updated
Aug 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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