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

NCT01699139 | Completed DMC

• 1 other identifier: NSC101-2314-B-182A-111
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Brain Ischemia

Keywords

supine position

Outcome Measures

Primary Outcomes (1)

• Change in apnea-hypopnea index (AHI)

  The AHI was defined as the average number of apneas and hypopneas per hour of sleep.

  change from baseline in apnea-hypopnea index at 1 week and change from baseline in apnea-hypopnea index at 2 weeks

Secondary Outcomes (5)

• Change in Augmentation Index

  Change from baseline in Augmentation Index at 1 week and change from baseline in Augmentation Index at 2 weeks

• Change in pulse wave velocity

  Change from baseline in pulse wave velocity at 1 week and change from baseline in pulse wave velocity at 2 weeks

• Change in 24-hour blood pressure profile

  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

• Change in the Patient Health Questionnaire 9-item depression scale (PHQ-9)

  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

• Change in the percentage of nocturnal supine positioning during sleep

  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 (2)

• Change in Barthel index

  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

• Tolerability of the positional devices

  12 weeks after wearing the positional devices

Study Arms (2)

positional device

ACTIVE COMPARATOR

Device: positional device

lumbar corset

SHAM COMPARATOR

Device: lumbar corset

Interventions

positional device 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.

positional device

lumbar corset 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.

Also known as: brand name: HEAVY-DUTY WAIST BINDER

lumbar corset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• unclear consciousness
• unstable vital sign or neurologic sign
• unstable medical conditions

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Brain Ischemia; Deception

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Chungyao Chen, M.D.

  Chang Gung Memorial Hospital, Keelung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 3, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2012-08

Locations

TW (1)