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CPAP on Acute Stroke and OSA

Primary Purpose

Stroke, Acute, Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CPAP
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring obstructive sleep apnea, stroke, continuous positive airway pressure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Time from onset of stroke symptoms to hospital arrival <2 weeks .
  2. Stroke is documented with brain magnetic imaging or computed tomography
  3. Competency to provide informed consent.
  4. Moderate to severe obstructive sleep apnea being established with the use of a home sleep-study screening device (ApneaLink).
  5. Epworth sleepiness scale≦10.

Exclusion Criteria:

  1. Having received CPAP for obstructive sleep apnea prior to admission.
  2. History of pneumothorax or brain surgery.
  3. Coexisting heart failure or renal failure or persistent atrial fibrillation.
  4. Unable to wear a nasal or nasal-oral mask.
  5. Concomitant uncontrolled infection.
  6. Swallowing difficulty or episodes of choking due to stroke
  7. Coexisting central nervous diseases such as dementia

Sites / Locations

  • Far Eastern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP group

Usual-care group

Arm Description

Subjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke.

Subjects will receive optimal standard therapy for acute stroke.

Outcomes

Primary Outcome Measures

Change in left atrium volume index (LAVI)
Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.

Secondary Outcome Measures

Serial change of NT-proBNP
Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.
Neurological and functional assessments-1
Change in National Institutes of Health (NIH) stoke scale will be assessed at baseline ,3, 6 and 12 months post randomization.
Neurological and functional assessments-2
Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.
Neurological and functional assessments-3
Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.
Change in Quality of life assessments
Change in Epworth sleepiness scale and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline, 3, 6 and 12 months post randomization.

Full Information

First Posted
June 30, 2020
Last Updated
July 9, 2020
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04458779
Brief Title
CPAP on Acute Stroke and OSA
Official Title
Cardiovascular Effects of Continuous Positive Airway Pressure in Patients With Acute Stroke and Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stroke affects 16.9 million individuals each year and is the second leading cause of death worldwide. Despite advances in pharmacologic therapy, morbidity , mortality and rates of hospitalization for stroke remain high. These data emphasize the importance of identifying all treatable conditions that could aggravate stroke. One such condition is obstructive sleep apnea (OSA). Sleep-related breathing disorders, including obstructive and central sleep apnea, often coexist with stroke. Compared to the general population, in whom OSA is the most common form of this breathing disorder with recent prevalence estimates of 22% of male and 17% of female , in the stroke population, the prevalence of OSA is much greater at 70% . Several randomized controlledtrials on OSA patients with stroke in acute or sub-acute stage showed that treating OSA with continuous positive airway pressure (CPAP) improved motor and functional outcomes, accelerated neurological recovery.Apart from the benefits in better neurological outcomes, secondary analyses of SAVE study suggested that CPAP treatment potentially help to reduce recurrence of stroke. Nevertheless, we don't have evidence yet from randomized control studies to prove CPAP treatment would reduce the recurrence of cardiovascular or cerebrovascular events. Traditionally, recurrence of cardiovascular or cerebrovascular events uses documented mortality, morbidity or hospitalization for heart failure, acute coronary syndrome or stroke as clinical endpoints. Recently, several studies showed that enlarged left atrium (LA) can serve as a predictor for recurrent stroke or cardiovascular events. On the other hand, a growing body of studies demonstrated that CPAP treatment reduce size of LA in those with OSA. Notably, all of these studies above are observational or retrospective in nature. To date, there are no prospective longitudinal randomized controlled trials reporting the effect of CPAP treatment of OSA on the change of size of LA. We therefore will undertake a randomized , controlled trial involving patients with stroke to test the primary hypothesis that treatment of OSA with CPAP would reduce the size of LA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, stroke, continuous positive airway pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP group
Arm Type
Experimental
Arm Description
Subjects will receive CPAP treatment in addition to optimal standard therapy for acute stroke.
Arm Title
Usual-care group
Arm Type
No Intervention
Arm Description
Subjects will receive optimal standard therapy for acute stroke.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.
Primary Outcome Measure Information:
Title
Change in left atrium volume index (LAVI)
Description
Change of LAVI will be assessed by transthoracic echocardiography at baseline and at 3, 6 and 12 months post randomization.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Serial change of NT-proBNP
Description
Change of NT-proBNP will be assessed at baseline and at 3, 6 and 12 months post randomization.
Time Frame
12 months
Title
Neurological and functional assessments-1
Description
Change in National Institutes of Health (NIH) stoke scale will be assessed at baseline ,3, 6 and 12 months post randomization.
Time Frame
12 months
Title
Neurological and functional assessments-2
Description
Change in modified Rankin scale will be assessed at baseline, 3, 6 and 12 months post randomization.
Time Frame
12 months
Title
Neurological and functional assessments-3
Description
Chang in Barthel-ADL index will be assessed at baseline, 3, 6 and 12 months post randomization.
Time Frame
12 months
Title
Change in Quality of life assessments
Description
Change in Epworth sleepiness scale and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline, 3, 6 and 12 months post randomization.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Numbers of cardiovascular or cerebrovascular events
Description
Numbers of cardiovascular or cerebrovascular events post randomization
Time Frame
12 months
Title
Time to cardiovascular or cerebrovascular events
Description
Time to cardiovascular or cerebrovascular events post randomization
Time Frame
12 months
Title
Numbers of all-cause hospitalizations
Description
Numbers of hospitalizations for any reason post randomization
Time Frame
12 months
Title
Number of deaths
Description
Numbers of deaths from all causes post randomization
Time Frame
12 months
Title
Time to deaths
Description
Time to deaths from all causes post randomization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Time from onset of stroke symptoms to hospital arrival <2 weeks . Stroke is documented with brain magnetic imaging or computed tomography Competency to provide informed consent. Moderate to severe obstructive sleep apnea being established with the use of a home sleep-study screening device (ApneaLink). Epworth sleepiness scale≦10. Exclusion Criteria: Having received CPAP for obstructive sleep apnea prior to admission. History of pneumothorax or brain surgery. Coexisting heart failure or renal failure or persistent atrial fibrillation. Unable to wear a nasal or nasal-oral mask. Concomitant uncontrolled infection. Swallowing difficulty or episodes of choking due to stroke Coexisting central nervous diseases such as dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Chen Lai, BD
Phone
8966-7000
Ext
1551
Email
sleepra01@gmail.com
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Chen Lai
Phone
8966-7000
Ext
1551
Email
sleepra01@gmail.com

12. IPD Sharing Statement

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CPAP on Acute Stroke and OSA

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