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

NCT ID: NCT00800397

Last Updated: 2009-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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WideMed LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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WideMed LTD.

Locations

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Morristown memorial hospital

Morristown, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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MorpheusHx002

Identifier Type: -

Identifier Source: org_study_id

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