Study on device to identify blocked breathing in patients during sleep
Phase 2
- Conditions
- Health Condition 1: 4- Measurement and Monitoring
- Registration Number
- CTRI/2024/06/068760
- Lead Sponsor
- Turtle Shell Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adults of age 18 to 80 years
Able to provide written informed consent
Weight above 40 to 120Kgs
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of Dozee in detection of sleep apnea in comparison with the gold standard PSGTimepoint: At Baseline during patient enrolment in the study
- Secondary Outcome Measures
Name Time Method Dozee classification of apnea severity according to standard AASM classification <br/ ><br>Dozee sensitivity in the classification of apnea according to standard <br/ ><br>AASM classification <br/ ><br>Dozee sensitivity in identifying all apneic events observed in the PSG <br/ ><br>Correlation between Dozee AHI values and PSG AHI <br/ ><br>Dozee Sleep stage classification and its correlation with sleep stages <br/ ><br>from PSG study <br/ ><br>Motion detection of Dozee compared to gross movement manual detection in the PSG study <br/ ><br>Snoring detection of Dozee compared to the snoring detection in the PSG study <br/ ><br>Hypoxic episodes detection by Dozee pulse oximeterTimepoint: At Baseline during patient enrolment in the study