StrokePhase 4BOSASTNCT00952211
Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
A Phase 4 study testing CPAP and CPAP at sub-therapeutic pressure in people with Stroke and Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Stroke, Obstructive Sleep Apnea
- What is being tested?
- CPAP and CPAP at sub-therapeutic pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke survivor in stroke rehabilitation unit
- age 45-85
- able to consent
- no prior treatment with CPAP
Who cannot join
- complex apnea
- known inflammatory disease
- neurological disease precluding patient's ability to consent and cooperate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Obstructive Sleep Apnea
- Being tested
- CPAP, CPAP at sub-therapeutic pressure
- Keywords
- stroke, obstructive sleep apnea, fatigue, quality of life
- Medical subject headings
- Stroke, Sleep Apnea, Obstructive, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP at therapeutic pressure during nighttime
CPAP at sub-therapeutic pressureDevice
CPAP delivered at sub-therapeutic pressure at nighttime
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | CPAP at therapeutic pressure Receives: Device: CPAP |
| sub-therapeutic CPAP | Sham comparator | CPAP administered at sub-therapeutic pressure Receives: Device: CPAP at sub-therapeutic pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States (POMS) - Fatigue Subscale
POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue
Measured: 10 days after beginning CPAP treatment
Secondary outcomes (1)
Hospital Anxiety and Depression (HADS) Scale -Depression Subscale
HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms
Measured: 10 days after beginning CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: problems with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel E. Dimsdale, M.D., University of California, San Diego
- Investigators
- Joel Dimsdale, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952211
- Sponsor's protocol ID
- HL091848
- Acronym
- BOSAST
- Status last verified
- Mar 2016
- First submitted
- 3 Aug 2009
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23019248
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
- ClinicalTrials.gov ID
- NCT00952211
- Acronym / sponsor ID
- BOSAST / HL091848
- Conditions
- Stroke, Obstructive Sleep Apnea
- Keywords
- stroke, obstructive sleep apnea, fatigue, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problems with recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Device: CPAPCPAP at therapeutic pressure |
| sub-therapeutic CPAP | Sham comparator | Device: CPAP at sub-therapeutic pressureCPAP administered at sub-therapeutic pressure |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stroke survivor in stroke rehabilitation unit
- age 45-85
- able to consent
- no prior treatment with CPAP
Key exclusion criteria (3 listed)
- complex apnea
- known inflammatory disease
- neurological disease precluding patient's ability to consent and cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPCPAP at therapeutic pressure during nighttime | Device | CPAP |
| CPAP at sub-therapeutic pressureCPAP delivered at sub-therapeutic pressure at nighttime | Device | sub-therapeutic CPAP |
Primary outcome
Profile of Mood States (POMS) - Fatigue Subscale
Time frame: 10 days after beginning CPAP treatment
POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue
1 secondary outcome
Hospital Anxiety and Depression (HADS) Scale -Depression Subscale
Time frame: 10 days after beginning CPAP treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23019248Tomfohr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Dimsdale, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP and CPAP at sub-therapeutic pressure in people with Stroke and Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Mood States (POMS) - Fatigue Subscale (time frame: 10 days after beginning CPAP treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.