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

NCT ID: NCT01699139

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-07-31

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.

Conditions

Sleep Apnea, Obstructive; Brain Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

positional device

Group Type: ACTIVE_COMPARATOR

positional device

Intervention Type: DEVICE

Avoidance of supine positioning was achieved by use of the commercially available ZZoma Positional Device, which is the FDA cleared class II positional medical device. The device is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam. It is contained in the nylon material with an associated Velcro belt. Zzoma is a positioner worn around the upper torso to restrict patient movement from side to supine.

lumbar corset

Group Type: SHAM_COMPARATOR

lumbar corset

Intervention Type: DEVICE

A lumbar (abdominal) binder is made of an elastic fabric with Velcro closure. Subjects wore the prefabricated lumbar corset during sleep and were positioned ad lib.

Interventions

positional device

Avoidance of supine positioning was achieved by use of the commercially available ZZoma Positional Device, which is the FDA cleared class II positional medical device. The device is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam. It is contained in the nylon material with an associated Velcro belt. Zzoma is a positioner worn around the upper torso to restrict patient movement from side to supine.

Intervention Type: DEVICE

lumbar corset

A lumbar (abdominal) binder is made of an elastic fabric with Velcro closure. Subjects wore the prefabricated lumbar corset during sleep and were positioned ad lib.

Intervention Type: DEVICE

Other Intervention Names

brand name: HEAVY-DUTY WAIST BINDER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chungyao Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Keelung

Locations

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

NSC101-2314-B-182A-111

Identifier Type: -

Identifier Source: org_study_id