Ischemic Stroke, Obstructive Sleep Apnea
Conditions
Keywords
Stroke, Sleep Apnea
Brief summary
Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke. Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night. Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.
Interventions
DEVICEEPAP
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults with an ischemic stroke (including TIA with infarction) within the prior 14 days
Exclusion criteria
1. Current use of any transnasal tube (eg dobhoff tube) 2. Current use of CPAP, mechanical ventilation, or supplemental oxygen 3. Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum 4. Severe heart disease (including severe heart failure) 5. Pathologically low blood pressure 6. An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum 7. Sores, abrasions, or skin or mucosal irritation on or around the nose. 8. Known pregnancy 9. Inability to provide informed consent 10. Use of alpha blockers or short acting nitrates 11. Permanent pacemaker 12. Sustained non-sinus cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea Index | night 1 and night 2 | Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model. |
Countries
United States
Participant flow
Recruitment details
Some subjects were discharged from the hospital between the first and second night and therefore dropped out.
Participants by arm
| Arm | Count |
|---|---|
| All Participants | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 60 years |
| Body mass index, self reported | 29.1 kg/m^2 |
| NIH Stroke Scale | 4 units on a scale |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Apnea-hypopnea Index
Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.
Time frame: night 1 and night 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EPAP Night | Apnea-hypopnea Index | 17.1 apneas plus hypopneas per hour |
| Control Night | Apnea-hypopnea Index | 25.2 apneas plus hypopneas per hour |
p-value: 0.18395% CI: [-14.4, 2.97]ANOVA