Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
Intervention1: DOZEE: Ballistocardiography based non invasive device. Each patient in the sleep lab will be subject simulatenous recording along with the comparator wihc will last approximately 5-9 h
Sponsors
Turtle Shell Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adults of age 18 to 80 years Able to provide written informed consent Weight above 40 to 120Kgs
Exclusion criteria
Exclusion criteria: Weight below 40 kgs and above 120 kgs. A likely need to receive or undergo a procedure/care during the testing period Have a pacemaker or defibrillator A significant medical condition in the judgment of the investigator which may compromise the study testing procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of Dozee in detection of sleep apnea in comparison with the gold standard PSGTimepoint: At Baseline during patient enrolment in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Dozee classification of apnea severity according to standard AASM classification Dozee sensitivity in the classification of apnea according to standard AASM classification Dozee sensitivity in identifying all apneic events observed in the PSG Correlation between Dozee AHI values and PSG AHI Dozee Sleep stage classification and its correlation with sleep stages from PSG study Motion detection of Dozee compared to gross movement manual detection in the PSG study Snoring detection of Dozee compared to the snoring detection in the PSG study Hypoxic episodes detection by Dozee pulse oximeterTimepoint: At Baseline during patient enrolment in the study | — |
Countries
India
Contacts
Public ContactDr Kumar Chokalingam
Turtle Shell Technologies Pvt Ltd
Outcome results
None listed