Clinical trial NCT01699139: The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke
Official title: The Effect of Positional Device on the Obstructive Sleep Apnea in Patients With Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Brain Ischemia
Keywords: supine position
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-10-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in apnea-hypopnea index (AHI)
timeFrame: change from baseline in apnea-hypopnea index at 1 week and change from baseline in apnea-hypopnea index at 2 weeks
Secondary outcomes:
measure: Change in Augmentation Index
timeFrame: Change from baseline in Augmentation Index at 1 week and change from baseline in Augmentation Index at 2 weeks
measure: Change in pulse wave velocity
timeFrame: Change from baseline in pulse wave velocity at 1 week and change from baseline in pulse wave velocity at 2 weeks
measure: Change in 24-hour blood pressure profile
timeFrame: Change from baseline in 24-hour blood pressure profile at 1 week and change from baseline in 24-hour blood pressure profile at 2 weeks
measure: Change in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
timeFrame: Change from baseline in the PHQ-9 at 1 week, change from baseline in the PHQ-9 at 2 weeks and change from baseline in the PHQ-9 at 12 weeks
measure: Change in the percentage of nocturnal supine positioning during sleep
timeFrame: Change from baseline in the percentage of nocturnal supine positioning at 1 week and change from baseline in the percentage of nocturnal supine positioning at 2 weeks
Other outcomes:
measure: Change in Barthel index
timeFrame: Change from baseline in Barthel index at 1 week, change from baseline in Barthel index at 2 weeks and change from baseline in Barthel index at 12 weeks
measure: Tolerability of the positional devices
timeFrame: 12 weeks after wearing the positional devices
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
Study officials:
affiliation: Chang Gung Memorial Hospital, Keelung
name: Chungyao Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: