Study Stopped
problems with recruitment
Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
BOSAST
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 stroke
Started Aug 2009
Shorter than P25 for phase_4 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 3, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
April 4, 2016
CompletedApril 4, 2016
March 1, 2016
1.8 years
August 3, 2009
January 27, 2016
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Profile of Mood States (POMS) - Fatigue Subscale
POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue
10 days after beginning CPAP treatment
Secondary Outcomes (1)
Hospital Anxiety and Depression (HADS) Scale -Depression Subscale
10 days after beginning CPAP treatment
Study Arms (2)
CPAP
ACTIVE COMPARATORCPAP at therapeutic pressure
sub-therapeutic CPAP
SHAM COMPARATORCPAP administered at sub-therapeutic pressure
Interventions
CPAP delivered at sub-therapeutic pressure at nighttime
Eligibility Criteria
You may qualify if:
- stroke survivor in stroke rehabilitation unit
- age 45-85
- able to consent
- no prior treatment with CPAP
You may not qualify if:
- complex apnea
- known inflammatory disease
- neurological disease precluding patient's ability to consent and cooperate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD
San Diego, California, 92103, United States
Related Publications (1)
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.
PMID: 23019248DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joel Dimsdale
- Organization
- UCSD
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Dimsdale, MD
UCSD
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 3, 2009
First Posted
August 6, 2009
Study Start
August 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 4, 2016
Results First Posted
April 4, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share