The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke
The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke
Supine positioning was reported to increase upper airway collapsibility, apnea frequency and
 duration. Positional therapy, designed to minimize supine sleep, was reported to be
 beneficial in the general sleep apnea population. As supine sleep is very common in stroke
 patients, positional therapy might also have therapeutic effects. Given differences between
 stroke patients with sleep apnea and the general sleep apnea patient, such as rolling
 ability, body mass index and daytime sleepiness, positional therapy results in the general
 population may not be applicable to the stroke patient.

 The effects of positional therapy in ischemic stroke patients with OSA have not been
 well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to
 test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine
 positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea
 improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The
 tolerability of positional therapy over a 3-month period in patients with ischemic stroke was
 also evaluated.
Phase 1:

 In the first phase, a randomized, controlled, two-period cross-over study design (AB/BA) was
 used with no washout period. After an acclimatization period (3 days), during which the
 compliance of the Positional Device was monitored, each patient was randomized into either
 Group I (sequence AB) or Group II (sequence BA). After commencement of treatment, the outcome
 measures were repeated on the last day of each treatment period. On the control night (B),
 subjects used the lumbar corset and were positioned ad lib.

 Phase 2:

 In the second phase of the study which began immediately after attainment of the first phase,
 subjects were randomized on a 1:1 basis, in a parallel group design, to 3 months of
 positional devices or sleeping ad lib. At 3 months later all subjects were interviewed face
 to face to determine the Barthel index and the Patient Health Questionnaire 9-item depression
 scale. Subjects in the positional devices group were also evaluated about devices adherence
 using the following questions: use of the device all nights, most nights, some nights, or no
 nights.
Inclusion Criteria:

 -  Patients with ischemic stroke (> 1month, within 12 months) and moderate-to-severe OSA
 (AHI>15) who could wear the positional devices not interfering with his/her sleep.

 Exclusion Criteria:

 -  unclear consciousness

 -  unstable vital sign or neurologic sign

 -  unstable medical conditions