| CTRI Number |
CTRI/2022/10/046183 [Registered on: 04/10/2022] 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
|
An exploratory study
to evaluate relationship between interoception
and sleep quality |
|
Scientific Title of Study
|
Interoception and Sleep: An exploratory study
to evaluate relationship between interoception
and sleep quality |
| Trial Acronym |
DZ_NIM_Slp |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra PN |
| Designation |
Associate Professor Department of Neurophysiology |
| Affiliation |
NIMHANS |
| Address |
1st floor, Sleep Laboratory at Centre for Consciousness Studies, Dept of Neurophysiology, NIMHANS Administrative block, WHRX 56W, Lakkasandra, Laljinagar, Wilson Garden, Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9448934488 |
| Fax |
|
| Email |
ravindrapinna@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 flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru
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 flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru
Bangalore
KARNATAKA
560038
India |
| Phone |
9611197910 |
| Fax |
|
| Email |
pooja@dozee.io |
|
|
Source of Monetary or Material Support
|
| Turtle Shell Technologies Private Limited City Centre, #40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038
|
|
|
Primary Sponsor
|
| Name |
Turtle Shell Technologies Private Limited |
| Address |
City Centre, #40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038 |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra P N |
NIMHANS |
1st Floor, Sleep Laboratory at Centre for Consciousness Studies, Dept. of Neurophysiology, NIMHANS Administrative Block, WHRX 56W, Lakkasandra, Laljinagar, Wilson Garden, Hosur Road
Bangalore
KARNATAKA |
9448934488
ravindrapinna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects between the age group of 20-70 years of age, both sexes |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy volunteers of ages >20 years and <70 years within weight range 40 kg - 125 kg
2. Provide informed consent for the participation in an overnight study at the sleep lab. |
|
| ExclusionCriteria |
| Details |
1. Subject has any history of medical and sleep disorder syndrome, drug or alcohol dependence and not under any medication as assessed by personal interviews.
2. Volunteers of ages <20 years and >70 years outside of the weight range 40 kg - 120 kg
3. Volunteers with disturbed sleep one night before the actual sleep recordings |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Validation of Dozee sleep staging, breathing rate, heart rate variability and snore detection to sleep lab polysomnography-based assessment.
2. Evaluating the impact of environment specifically light, sound and temperature on sleep quality
3. Evaluation of macrosleep architecture parameters such sleep stages duration, sleep stage percentage, sleep efficiency etc.
4. Evaluation of EEG dynamics (the synchrony, frequency, spectrum, amplitude, coherence and topography of the frequency bands- alpha, beta, theta, delta and gamma) associated with sleep states.
5. Evaluation of biological level of melatonin and cortisol before and after the sleep. |
At Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/10/2022 |
| 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="2"
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
|
The
present study aims:
1. To study the
relationship between sleep variables and interoceptive neural correlates using
dozee sleep quality algorithm.
2. To study the
biological and behavioural correlates of stress with subjective and objective
sleep variables
This is a single-arm
prospective study that assess introceptive awareness and concurrent sleep data
from Dozee and the polysomnography system. It is an observational study that is
conducted with healthy volunteers and not intended for diagnostic or
interventional purposes.
Dozee device
developed by Turtle Shell Technologies Pvt. Ltd., is intended for contactless
continuous monitoring of vital parameters (HR and RR), and screening for
abnormal changes in these parameters. The device uses the concept of
ballistocardiography and deploys piezoelectric sensors to capture the
micro-vibrations originating from cardiac contractions, upper respiratory tract
activity and body movements. This data is then analyzed by a proprietary
algorithm and the values of the vital parameters are generated. The device is
intended to be used to monitor individuals/patients greater than eighteen years
of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signs
during sleep and resting state. The setup includes placing a sensor under the
mattress, and a bedside unit on a nearby flat surface. The other components of
the setup are Power cords and Power adapter. Thus, a power outlet with
sufficient plug sockets near the bed will be required.
|