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

NCT00800397 | Completed DMC

• 1 other identifier: MorpheusHx002
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Detection of Cheyne Stokes respiration

  over night

Secondary Outcomes (4)

• Sleep and sleep apnea parameters

  over night

• AH>=15

  over night

• plethysmography derived respiration signal

  over night

• Total duration of Cheyne Stokes

  over night

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cardiac and suspected sleep disordered breathing patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• WideMed LTD.: lead

Study Sites (1)

Morristown memorial hospital

Morristown, New Jersey, 07962, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 12, 2009

Record last verified: 2009-08

Locations

US (1)