The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke

Completed

Phase N/A Results N/A

Update History

11 Feb '15
A location was updated in Keelung.
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The overall status was removed for Chang Gung Memorial Hospital, Keelung.
5 Apr '13
The description was updated.
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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.
Old
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, subjects were randomized on a 1:1 basis, in a parallel group design, to 3 months of positional devices or standard positioning, which started immediately after completion of the first phase. At 3 months later we conducted a interview with all subjects to determine functional outcome measured by Barthel index and the Patient Health Questionnaire 9-item depression scale. Those randomized to the positional devices were also queried about devices adherence using a Likert scale: use of the device all nights, most nights, some nights, or no nights.
22 Mar '13
The Summary of Purpose was updated.
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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.
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Body position during sleep influences the severity of sleep apnea in more than half of obstructive sleep apnea (OSA) patients. Supine positioning is associated with an increase in upper airway collapsibility and thus an increase in apnea frequency and duration. Positional therapy, designed to minimize supine sleep, has a beneficial effect in the general sleep apnea population, although not as great as continuous positive airway pressure (CPAP). As supine sleep is very common in acute stroke patients, positional therapy that reduces supine sleep may have particular relevance to the stroke population. Given differences between stroke patients with sleep apnea and the general sleep apnea patient, such as 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 after ischemic stroke, and (2) ischemic stroke patients have less severe sleep apnea, as reflected by apnea-hypopnea index (AHI), during positional therapy. We also sought to explore the tolerability of positional therapy over a 3-month period.