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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800397
• Other study ID #: MorpheusHx002
• Status: Completed
• Phase: N/A
• First received: December 1, 2008
• Last updated: August 11, 2009
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: WideMed LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parasomnias
• Sleep Apnea
• Sleep Disorders

Locations

Country	Name	City	State
United States	Morristown memorial hospital	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
WideMed LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Cheyne Stokes respiration		over night	No
Secondary	Sleep and sleep apnea parameters		over night	No
Secondary	AH>=15		over night	No
Secondary	plethysmography derived respiration signal		over night	No
Secondary	Total duration of Cheyne Stokes		over night	No