| CTRI Number |
CTRI/2024/04/066167 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial to study the convenience and usability of newly proposed adaptive positive airway pressure mask for obstructive sleep apnea |
|
Scientific Title of Study
|
Breath Assist: A Continuous Positive Airway Pressure System |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayanthi T |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department Of Biomedical Engineering,
College of Engineering and Technology,
Srm Institute Of Science And Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09840490315 |
| Fax |
|
| Email |
jayantht@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayanthi T |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department Of Biomedical Engineering,
College of Engineering and Technology,
Srm Institute Of Science And Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09840490315 |
| Fax |
|
| Email |
jayantht@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jayanthi T |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department Of Biomedical Engineering,
College of Engineering and Technology,
Srm Institute Of Science And Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09840490315 |
| Fax |
|
| Email |
jayantht@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| DST SEED-TIDE, Department of Science and Technology,
Technology Bhavan, New Mehrauli Road,,
New Delhi 110 016.
Telephone: 91 11 26590215 |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
DST SEED-TIDE, Department of Science and Technology, Technology Bhavan, New Mehrauli Road,, New Delhi 110 016. Telephone: 91 11 26590215 |
| Type of Sponsor |
Government funding agency |
|
|
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 Subramanian S |
SRM Medical College Hospital And Research Centre |
Department of Pulmonary medicine, Floor 2, room no: ,SRM Nagar
Potheri
Chengalpattu District
Kancheepuram
TAMIL NADU |
9488507784
drssmani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee (IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breath assist device |
Cordless CPAP device, will be used for mild OSA therapy |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with AHI greater than 5
Subjects complaining of hypersomnia
Mild and moderate sleep apnea
subjects with increased carbon dioxide level |
|
| ExclusionCriteria |
| Details |
Severe or chronic respiratory ailment
Subjects diagnosed with pneumothorax
Subjects with Hypercapnia, Respiratory acidosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in AHI (Apnea Hypopnea Index) of the user, SpO2 will be improved during therapy |
min 4 to 8 hours of single time usage during night sleep |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved sleep cycle, reduced ODI (oxygen desaturation index), SQI (sleep quality index) will be improved. |
from 2 weeks of usage. |
|
|
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)
|
15/05/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The mask will be evaluated for patient comfort and fit
after subject selection based on the above criteria. The subject will enter weight and ramp speed. The mask
delivers the desired pressure. The subject wears the suggested mask one night, then utilizes
normal CPAP apparatus in the hospital the next night. The data is used to evaluate
the mask’s efficiency. (Justification: The patient’s night sleep is not
disturbed, and data from both devices on different night studies can assist in investigating and verifying the prototype)Both studies monitor SpO2 concurrently using a Beurer
Pulse Oximeter. •Then, data is analyzed to determine mask efficacy |