Clinical trial NCT00952211: Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
Official title: Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Stroke
Obstructive Sleep Apnea
Keywords: stroke
obstructive sleep apnea
fatigue
quality of life
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 3
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Profile of Mood States (POMS) - Fatigue Subscale
timeFrame: 10 days after beginning CPAP treatment
Secondary outcomes:
measure: Hospital Anxiety and Depression (HADS) Scale -Depression Subscale
timeFrame: 10 days after beginning CPAP treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD
name: Joel Dimsdale, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.