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Burden of Obstructive Sleep Apnea in Stroke (BOSAST) (BOSAST)

Primary Purpose

Stroke, Obstructive Sleep Apnea

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CPAP
CPAP at sub-therapeutic pressure
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring stroke, obstructive sleep apnea, fatigue, quality of life

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke survivor in stroke rehabilitation unit
  • age 45-85
  • able to consent
  • no prior treatment with CPAP

Exclusion Criteria:

  • complex apnea
  • known inflammatory disease
  • neurological disease precluding patient's ability to consent and cooperate

Sites / Locations

  • UCSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

CPAP

sub-therapeutic CPAP

Arm Description

CPAP at therapeutic pressure

CPAP administered at sub-therapeutic pressure

Outcomes

Primary Outcome Measures

Profile of Mood States (POMS) - Fatigue Subscale
POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue

Secondary Outcome Measures

Hospital Anxiety and Depression (HADS) Scale -Depression Subscale
HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms

Full Information

First Posted
August 3, 2009
Last Updated
March 7, 2016
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00952211
Brief Title
Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
Acronym
BOSAST
Official Title
Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
problems with recruitment
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There are two purposes of this study. The first purpose is to define the frequency of obstructive sleep apnea in stroke survivors as well as its association with fatigue and quality of life. The second purpose is to determine if continuous positive airways pressure (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.
Detailed Description
Stroke survivors frequently complain of fatigue, depressive symptoms, and decreased cognitive functioning. These burdens complicate the recovery and rehabilitation from stroke. While there may be many contributing factors to these burdens, one factor in particular may be both terribly common and yet readily susceptible to intervention. Consistent reports from around the world demonstrate that >50% of stroke patients have obstructive sleep apnea (OSA), a disorder that is also associated with fatigue, depressive symptoms, and decreased cognitive functioning. OSA is also associated with increases in inflammatory products which themselves are associated with the same array of burdens. This study will examine inpatients at a stroke rehabilitation center. Patients' sleep will be studied. Patients with OSA will be randomized to 10 days treatment double blind with either continuous positive airways pressure (CPAP) treatment or to sub-therapeutic CPAP treatment. After 10 days of treatment, the OSA patients and the stroke patient without OSA will be restudied. The study will shed light on the impact of OSA on stroke patients' burdens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Obstructive Sleep Apnea
Keywords
stroke, obstructive sleep apnea, fatigue, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
CPAP at therapeutic pressure
Arm Title
sub-therapeutic CPAP
Arm Type
Sham Comparator
Arm Description
CPAP administered at sub-therapeutic pressure
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP at therapeutic pressure during nighttime
Intervention Type
Device
Intervention Name(s)
CPAP at sub-therapeutic pressure
Intervention Description
CPAP delivered at sub-therapeutic pressure at nighttime
Primary Outcome Measure Information:
Title
Profile of Mood States (POMS) - Fatigue Subscale
Description
POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue
Time Frame
10 days after beginning CPAP treatment
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression (HADS) Scale -Depression Subscale
Description
HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms
Time Frame
10 days after beginning CPAP treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke survivor in stroke rehabilitation unit age 45-85 able to consent no prior treatment with CPAP Exclusion Criteria: complex apnea known inflammatory disease neurological disease precluding patient's ability to consent and cooperate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Dimsdale, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23019248
Citation
Tomfohr LM, Hemmen T, Natarajan L, Ancoli-Israel S, Loredo JS, Heaton RK, Bardwell W, Mills PJ, Lee RR, Dimsdale JE. Continuous positive airway pressure for treatment of obstructive sleep apnea in stroke survivors: what do we really know? Stroke. 2012 Nov;43(11):3118-23. doi: 10.1161/STROKEAHA.112.666248. Epub 2012 Sep 27. No abstract available.
Results Reference
derived

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Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

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