Bilevel Positive Pressure Ventilation (BIPAP)in Patients With Sleep Disorders Breathing (SDB)and Congestive Heart Failure (CHF):Comparison of Two Diagnostic Methods

PHASE3UnknownINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Symptomatic Congestive Heart Failure
Interventions
DEVICE

watch-pat

"The Watch-PAT is a home sleep testing (HST) device. The Watch-PAT is a patient-worn, self-contained, non-invasive device used in the patient's home.~The Watch-PAT diagnoses obstructive sleep apnea (OSA) by measuring the PAT signal, heart rate, oxygen saturation, and actigraphy. The PAT signal is a validated surrogate measure of sympathetic activation that is associated with apneic events and respiratory effort related arousals (RERA). The Watch-PAT provides measures of all the OSA indices, i.e., Apnea Hypopnea Index (AHI), Respiratory Disturbances Index (RDI), and Oxygen Desaturation Index (ODI), which enable accurate assessment of the presence and severity of OSA and its effect on sleep architecture, sleep quality.~Based on the PAT and actigraphy signals, Watch-PAT differentiates between sleep and wake and detects sleep stages (light, deep, and REM) providing, the effect on additional specific conditions such as REM related apnea."

Trial Locations (1)

Unknown

RECRUITING

Meir Medical Center, Kfar Saba

Sponsors
All Listed Sponsors
lead

Meir Medical Center

OTHER