CTRI Number |
CTRI/2016/07/007104 [Registered on: 20/07/2016] Trial Registered Retrospectively |
Last Modified On: |
22/08/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Sleep Disordered Breathing in stroke patients:Effect of treatment trial. |
Scientific Title of Study
Modification(s)
|
Role of continuous positive airway pressure therapy for sleep disordered breathing in prevention of stroke recurrence and other vascular events and in improvement of neuropsychological outcome- A Prospective longitudinal study. |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Garima Shukla |
Address |
Room No.2
6th floor,
C.N.Center,
All India Institute of Meddical sciences.
South DELHI 110017 India |
Phone |
011-26593785 |
Fax |
|
Email |
garimashukla@hotmail.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Garima Shukla |
Address |
Room No.2
6th floor,
C.N.Center,
All India Institute of Meddical sciences.
South DELHI 110017 India |
Phone |
011-26593785 |
Fax |
|
Email |
garimashukla@hotmail.com |
|
Details Contact Person Public Query
|
Name |
Dr Garima Shukla |
Address |
Room No.2
6th floor,
C.N.Center,
All India Institute of Meddical sciences.
South DELHI 110017 India |
Phone |
011-26593785 |
Fax |
|
Email |
garimashukla@hotmail.com |
|
Source of Monetary or Material Support
|
Department of Science and Technology, India |
|
Primary Sponsor
|
Name |
Department of Science and Technology |
Address |
Shaheed Jeet Singh Marg, Block C, Adchini, New Delhi, DL 110016
011 2656 7373 |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Garima Shukla |
All India Institute of Medical Sciences, New Delhi |
Room No. 602,
Department of Neurology,
C.N., Center,
AIIMS, Ansari Nagar South |
1126593785 1126593785 director@aiims.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
All India Institute of Medical sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Stroke Patients |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
APAP(Auot positive airway pressure) |
This is gold standard treatment to treat obstructive sleep apnea patients. |
Comparator Agent |
No Treatment for OSA |
No APAP treatment will be provided to patients of OSA with Stroke |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
All patients presenting to neurology service, All India Institute of Medical sciences, New Delhi, with history suggestive of first arterial stroke with in 6 weeks from ictus,
-and with CT Scan or MRI evidence of the same,
-with or without cognitive impairment and
-those who do not require life support will be enrolled in the study. |
|
ExclusionCriteria |
Details |
Patients with previous history of stroke.
Patients with history of other neurological illness like Parkinsons disease, Neuro-Infections, Neuromuscular disorders and others.
Patients with known sleep disorders apart from sleep disordered breathing. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Their Neurological Out come (By Modified Rankin Scale and Barthel Index.
Cognitive status.
New Vascular events in form of stroke, Myocardial ischemia or Infarction.
Death. |
Three months,Six Months,One Year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Neuropsychological outcome |
6 months, one year |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
18/09/2009 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NA |
Brief Summary
|
The Prevalence of obstructive sleep apnea and sleep disordered breathing in general in patients with stroke has been found to range from 50% to 80%. Recently, SDB has been shown to be an independent risk factor for stroke. However, their is their is little evidence in existing literature on whether treatment of SDB with CPAP therapy, has any effect on prevention of new vascular events, especially recurrence after stroke. This study being planned to assess if treatment of SDB with CPAP in patients with stroke has any role in prevention of new onset vascular events(cardiac ischemia, infarction, stroke recurrence) or death; and whether it has any role in the neuropsychological or cognitive and neurological outcome following stroke. Our hypothesis is that patients of stroke with SDB can obtain benefit with CPAP therapy as regards occurrence of new vascular events and their neurological outcome. The study is proposed to be randomized control trial conscious patients of stroke evaluated clinically and through a polysomnography, diagnosed to have SDB forming the population under study. One group shall be randomized to CPAP therapy and slandered medical therapy and the other to receive only best medical therapy. The primary end point of the study would be occurrence of new vascular events or death and the secondary end points would be neuropsychological outcome and neurological outcome at 3,6 and 12 months. |