Obstructive Sleep Apnea, Stroke
Conditions
Keywords
obstructive sleep apnea, stroke, OSA, CPAP, continuous positive airway pressure
Brief summary
The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.
Detailed description
Stroke is the leading cause of adult disability in the United States, yet there are very few treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper airway blockage that occurs during sleep--is common after stroke, affecting more than half of stroke patients. The most common treatment for obstructive sleep apnea in the general population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep. The objective of this single-center, prospective, randomized study is to evaluate CPAP treatment in post-stroke patients. Participants will go through a medical interview, a brief neurological examination, and a sleep study to screen them for OSA. Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP (placebo). This project promises to establish feasibility, develop design and identify suitable outcome measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue, and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all stroke patients will become available.
Interventions
DEVICEcontinuous positive airway pressure or CPAP
RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
DEVICEsham CPAP
sham CPAP
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic stroke within 7 days of planned polysomnography/sleep screening study * Modified Rankin Scale score \>1 * If of child-bearing potential, has a negative urine or serum pregnancy test
Exclusion criteria
* Decompensated heart failure * Cardiac or respiratory arrest within the past 3 months * Myocardial infarction within the past 3 months * Severe pneumonia * Hypertension refractory to treatment * Any other unstable medical condition which is thought to interfere with participation * Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP * Previous pneumothorax * Bullous emphysema * Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP * Acute sinus or ear infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. | 3 months | — |
| Number of Subjects Who Withdraw From Study. | 3 months | Prespecified outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index | 3 months | Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent). |
Countries
United States
Participant flow
Recruitment details
Patients enrolled from inpatient neurology service.
Participants by arm
| Arm | Count |
|---|---|
| Active Continuous Positive Airway Pressure (CPAP) | 15 |
| Sham Continuous Positive Airway Pressure (CPAP) Subtherapeutic CPAP | 17 |
| Total | 32 |
Baseline characteristics
| Characteristic | Sham Continuous Positive Airway Pressure (CPAP) | Active Continuous Positive Airway Pressure (CPAP) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 7 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 8 Participants | 13 Participants |
| Age Continuous | 74 years STANDARD_DEVIATION 16 | 61 years STANDARD_DEVIATION 16 | 65 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 17 participants | 15 participants | 32 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 14 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
Primary
Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.
Time frame: 3 months
Population: Data not available on one sham participant (lowering n from 11 to 10 in the shame group).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active CPAP | Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. | 53 Hours/participant |
| Sham CPAP | Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. | 74 Hours/participant |
Primary
Number of Subjects Who Withdraw From Study.
Prespecified outcome.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active CPAP | Number of Subjects Who Withdraw From Study. | 13 participants |
Secondary
Barthel Index
Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active CPAP | Barthel Index | 95 units on a scale (range 0-100) |
| Sham CPAP | Barthel Index | 100 units on a scale (range 0-100) |