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	Name  Address  NIL  NIL
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	Status  Not Applicable
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.