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CTRI Number  CTRI/2022/10/046522 [Registered on: 17/10/2022] Trial Registered Prospectively
Last Modified On: 12/04/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Dozee as a screening tool for sleep apnea detection and classification 
Scientific Title of Study   Dozee as a Screening Tool for Sleep Apnea Detection and Classification 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Uma K Maheshwari 
Designation  Professor, Pulmonary Medicine 
Affiliation  St. John’s Medical College Hospital 
Address  Department of Pulmonary Medicine St. John’s Medical College Hospital St. John’s National Academy of Health Sciences Sarjapur Road Bangalore Karnataka 560034

Bangalore
KARNATAKA
560034
India 
Phone  9843702412  
Fax    
Email  umamohan99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pooja Kadambi  
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies  
Address  Turtle Shell Technologies, City Centre, #40, Ground & Mezzanine Floor, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038

Bangalore
KARNATAKA
560038
India 
Phone  9611197910  
Fax    
Email  pooja@dozee.io  
 
Details of Contact Person
Public Query
 
Name  Pooja Kadambi  
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies  
Address  Turtle Shell Technologies, City Centre, #40, Ground & Mezzanine Floor, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038


KARNATAKA
560038
India 
Phone  9611197910  
Fax    
Email  pooja@dozee.io  
 
Source of Monetary or Material Support  
Turtle Shell Technologies, City Centre, #40, Ground & Mezzanine Floor, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038 
 
Primary Sponsor  
Name  Turtle Shell Technologies Private Limited  
Address  Turtle Shell Technologies, City Centre, #40, Ground & Mezzanine Floor, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038 
Type of Sponsor  Other [Medical Device] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uma K Maheshwari  St. John’s Medical College Hospital  3rd Floor Oncology Block Department of Pulmonary Medicine St. John’s Medical College Hospital St. John’s National Academy of Health Sciences Sarjapur Road Bangalore Karnataka 560034
Bangalore
KARNATAKA 
9843702412

umamohan99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - St. Johns Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To classify OSA severity based on the events detected by the Dozee device and
compare it’s accuracy obtained from the gold standard test, Polysomnography (PSG) 
At Baseline during patient enrolment in the study 
 
Secondary Outcome  
Outcome  TimePoints 
1. Dozee’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. Dozee’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 study 
At Baseline during patient enrolment in the study 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Obstructive Sleep Apnea (OSA) is a condition where the upper airway muscles relax resulting in airflow obstruction. Central Sleep Apnea is a condition where there is no evidence of complete obstruction but associated with reduced airflow and respiratory effort. Complex sleep apnea syndrome is a combination of both obstructive and central sleep apnea [1]. According to AASM manual apnea and hypopnea are defined as follows: Apnea is flow limitation of more than or equal to 90% for atleast 10 seconds whereas hypopnea is fall in signal excursion for more than or equal to 30% with 3% drop in saturation or 4% desaturation with an arousal.[2].

Polysomnography (PSG) is the gold standard for detecting and assessing sleep apnea. It is performed overnight on subjects in a resource-intensive specialised sleep centre, with the subjects wearing encephalography (EEG) electrodes, oronasal airflow sensors, thoracic and abdominal respiratory inductive plethysmography (RIP) belts, electrocardiography (ECG) sensors, an oxygen saturation finger-clip sensor, a body position sensor. This arrangement is very distracting to the individual and interferes with a decent night’s sleep. Furthermore, the PSG approach necessitates the use of well-trained personnel and is a costly procedure [3]. Because PSG is such a resource-intensive process, researchers are constantly looking for a simpler, less demanding, and intrusive way to screen for sleep apnea first, and then propose PSG based on the severity of the screening test.

Ballistocardiography (BCG) is a promising approach that uses a non-invasive way to quantify the body motion caused by blood ejection during each cardiac cycle [8]. BCG can be used to measure the micro body motions produced during each cardiac contraction [9], as well as detect breathing, snoring, and limb movements [4,5], and it can also be made to work in a contact-free and non-wearable manner. Thus, BCG can be utilised to overcome the PSG system’s problems in a non-invasive way.

Dozee, developed by Turtle Shell Technologies employs the concept of BCG. Dozee which is placed beneath the mattress, detects micro-vibrations, from which proprietary algorithms derive parameters such as heart rate, respiration, stress levels, restlessness, and sleep quality. It has been validated for heart rate (HR), respiration rate (RR), and movement measurement. Contact accessories such as SpO2 are also included. When compared to the PSG, Dozee is far more user-friendly and comfortable for the subjects. Since BCG is contactless there is very little risk to the patients.

1. Jayaraj R, Mohan J, Kanagasabai A. A Review on Detection and Treatment Methods of Sleep Apnea. J Clin Diagn Res. 2017;11(3):VE01‐VE03.

2. Gould GA, Whyte KF, Rhind GB, et al. The sleep hypopnea syndrome. Am Rev Respir Dis. 1988;137(4):895‐898. doi:10.1164/ajrccm/137.4.895.

3. Wang, Z., Zhou, X., Zhao, W., Liu, F., Ni, H., & Yu, Z. (2017). Assessing the severity of sleep apnea syndrome based on ballistocardiogram. PLOS ONE, 12(4), e0175351. doi:10.1371/journal.pone.0175351

4. V. Saran, G. Kumar, U. Dhawan and G. Parchani, "Unsupervised Identification of Cardiac Contraction through Ballistocardiography," 2018 IEEE-EMBS Conference on Biomedical Engineering and Sciences (IECBES), Sarawak, Malaysia, 2018, pp. 42-47, doi: 10.1109/IECBES.2018.8626652.

5. Saran V., Kumar G., Parchani G. (2019) Unsupervised Extraction of Respiration Cycles Through Ballistocardiography. In: Luhach A., Jat D., Hawari K., Gao XZ., Lingras P. (eds) Advanced Informatics for Computing Research. ICAICR 2019. Communications in Computer and Information Science, vol 1075. Springer, Singapore. https://doi.org/10.1007/978-981-15-0108-1_14


 
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