Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
None listed
Sponsors
Turtle Shell Technologies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults of age 18-80 2. Able to provide written informed consent 3. Weight above 40 kgs 4. Recommended for a level 1 sleep lab study to test for sleep apnea
Exclusion criteria
Exclusion criteria: 1. Weight above 150kg 2. A likely need to receive or undergo a procedure/care during the testing period 3. Have a pacemaker or defibrillator 4. A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To classify OSA severity based on the events detected by the Dozee device and compare itâ??s accuracy obtained from the gold standard test, Polysomnography (PSG)Timepoint: At Baseline during patient enrolment in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dozeeâ??s sensitivity in the classification of apnea according to standard American Association of Sleep Medicine (AASM) classification 2. Correlation of Apnea Hypopnea Index (AHI) from Dozee vs PSG 3. Dozeeâ??s Sleep stage classification algorithm and its correlation with sleep stages from PSG study 4. Motion detection of Dozee compared to gross movement manual detection in the PSG studyTimepoint: At Baseline during patient enrolment in the study | — |
Countries
India
Contacts
Public ContactPooja Kadambi
Turtle Shell Technologies
Outcome results
None listed