Obstructive Sleep Apnea, Stroke
Conditions
Keywords
stroke, obstructive sleep apnea, fatigue, quality of life
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.
Interventions
DEVICECPAP
CPAP at therapeutic pressure during nighttime
DEVICECPAP at sub-therapeutic pressure
CPAP delivered at sub-therapeutic pressure at nighttime
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Mood States (POMS) - Fatigue Subscale | 10 days after beginning CPAP treatment | POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression (HADS) Scale -Depression Subscale | 10 days after beginning CPAP treatment | HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms |
Countries
United States
Participant flow
Recruitment details
The study opened for enrollment on 9/16/09 at San Diego Rehabilitation Institute. Enrollment was halted in April 2011 and the study terminated due to low recruitment numbers.
Participants by arm
| Arm | Count |
|---|---|
| CPAP CPAP at therapeutic pressure
CPAP: CPAP at therapeutic pressure during nighttime | 3 |
| Sub-therapeutic CPAP CPAP administered at sub-therapeutic pressure
CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | CPAP | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 1 participants | 1 participants |
| Age, Categorical Between 18 and 65 years | 2 participants | 2 participants |
| Gender Female | 2 participants | 2 participants |
| Gender Male | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Profile of Mood States (POMS) - Fatigue Subscale
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
Population: Data only available for 2 subjects; one subject did not provide data for this questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPAP | Profile of Mood States (POMS) - Fatigue Subscale | 10 units on a scale | Standard Deviation 2.83 |
Secondary
Hospital Anxiety and Depression (HADS) Scale -Depression Subscale
HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms
Time frame: 10 days after beginning CPAP treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPAP | Hospital Anxiety and Depression (HADS) Scale -Depression Subscale | 8 units on a scale | Standard Deviation 5 |