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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00800397
Enrollment
80
Registered
2008-12-02
Start date
2007-12-31
Completion date
2008-12-31
Last updated
2009-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

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.

Interventions

None listed

Sponsors

WideMed LTD.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Detection of Cheyne Stokes respirationover night

Secondary

MeasureTime frame
Sleep and sleep apnea parametersover night
AH>=15over night
plethysmography derived respiration signalover night
Total duration of Cheyne Stokesover night

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026