| CTRI Number |
CTRI/2018/04/013320 [Registered on: 17/04/2018] Trial Registered Prospectively |
| Last Modified On: |
17/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Registry |
| Study Design |
Other |
|
Public Title of Study
|
Sleep disorder- Indian Registry |
|
Scientific Title of Study
|
"Sleep- Apnoea Indian Registry (S-AIR)" |
| Trial Acronym |
S-AIR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himanshu Garg |
| Designation |
Head, Respiratory Critical Care Sleep Medicine, |
| Affiliation |
Artemis Hospital |
| Address |
Artemis Hospital
Department of Respiratory Critical Care Sleep Medicine
Ground floor, Room No 1017
Sector 51, Gurgaon.
Gurgaon
HARYANA
Gurgaon-122001
India |
| Phone |
9717156157 |
| Fax |
|
| Email |
drhimgarg@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Garg |
| Designation |
Head, Department of Respiratory Critical Care Sleep Medicine |
| Affiliation |
|
| Address |
Artemis Hospital
Department of Respiratory Critical Care Sleep Medicine
Ground floor,Room no 1017
Sector 51.Gurgaon.
Gurgaon
HARYANA
Gurgaon-122001
India |
| Phone |
9717156157 |
| Fax |
|
| Email |
drhimgarg@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Garg |
| Designation |
Head, Department of Respiratory Critical Care Sleep Medicine Critical Care Sleep Medicine |
| Affiliation |
|
| Address |
Artemis Hospital
Department of Respiratory Critical Care Sleep Medicine
Ground floor, Room no-1017
Sector 51, Gurgaon.
Gurgaon
HARYANA
Gurgaon-122001
India |
| Phone |
9717156157 |
| Fax |
|
| Email |
drhimgarg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Chest Society (ICS)
K.E.M. Hospital
Department of Chest Medicine
Acharya Dondemarg Parel
Mumbai
Maharashtra-400012 |
|
|
Primary Sponsor
|
| Name |
Indian Chest Society |
| Address |
KEM Hospital
Acharya Donde Marg
Parel,Mumbai
Maharashtra-400012. |
| Type of Sponsor |
Other [Non Government Research Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himanshu Garg |
Artemis Hospitals |
Department of Respiratory AND Critical Care Sleep Medicine Ground FLOOR, Room No-1017, SECTOR 51, Gurgaon-122001
Gurgaon
HARYANA
122001
India
Gurgaon
HARYANA |
9540156157
drhimgarg@yahoo.com |
| Dr Raja Dhar |
Fortis Hospital |
Pulmonology Department
Level-3, Room No-409
730 Anandapur,EM Bypass Road,
Kolkata-700107
Kolkata
WEST BENGAL |
9831855512
docaardee@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences |
Approved |
| Fortis Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
A clinical history consistent with sleep apnea, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.A clinical history consistent with sleep apnea (excessive daytime sleepiness, hypopnea, apnea, altered sleep quality, morning headaches,daytime tiredness)
2.patient diagnosed with sleep apnea using Polysomnography(PSG)/Home Sleep Study test(level 1,2,3)
|
|
| ExclusionCriteria |
| Details |
1.any other sleep related syndrome not overlapping with sleep apnea
2.Age <18 years
3.Delayed sleep syndrome
4.Patients who have not undergone Polysomnography test
5.Patients who are unable or unwilling to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will create an Indian multi centred Sleep apnea database |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Will create an Indian multi centred Sleep apnea database |
5 years |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
26/04/2018 |
| 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="5"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This registry is seeking to establish a
register of patients diagnosed with Sleep Apnoea (SA) in India in collaboration
with Indian Chest Society (ICS), AVISS HEALTH and Artemis Hospital, Gurgaon. We
wish to know more about how we treat SA and how many patients are there in
INDIA with this condition. One way of doing this is to record information about
patients that are diagnosed with SA. As a part of this registry we will store
simple informations about enrolled pt’s age,
the results of polysomnography tesst and the treatments that the pts have
received. This will help us in describing the impact of SA on the pt, and on
healthcare in India. The data collected in the registry will help us to
evaluate how well treatment works and help to design better clinical trials by
understanding more about the disease.
|