Positional Therapy After Stroke

NCT ID: NCT01047709

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-05-31

Brief Summary

Stroke is the leading cause of adult disability and the third leading cause of death in the United States. Unfortunately, there are few therapies that have been proven to improve stroke outcome. Sleep apnea is an emerging stroke risk factor and has a well established association with higher mortality and poor functional outcome following stroke. Over half of acute stroke patients have sleep apnea, suggesting that it may be a important target for therapy. Attenuation of sleep apnea severity may result in improved stroke outcomes. However, the standard treatment for sleep apnea is not well-tolerated among stroke patients. An alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute stroke patients, and therefore this treatment may have particular relevance to the stroke population. The proposed study will be conducted in two phases. The first phase is a randomized, crossover design in which acute stroke patients will be given positional treatment (to avoid supine sleep) on one night during their stroke hospitalization. This will be compared with another night of sleeping without positional therapy. The order of treatments (standard vs positional therapy) will be random. The first phase will demonstrate the proof of concept: that stroke patients given positional therapy to avoid supine sleep will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with positional therapy. In the second phase, those identified to have sleep apnea will be randomized to receive positional therapy at home for three months, or standard therapy. This second phase will demonstrate the adherence/feasibility of three months of positional therapy, and will allow us to estimate effect size based on a functional outcome measure. The data obtained from this pilot clinical trial are essential to plan a large efficacy study.

Conditions

Sleep Apnea; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

positional therapy

Avoidance of supine positioning.

Group Type: EXPERIMENTAL

Positional therapy including the use of a special pillow

Intervention Type: DEVICE

Avoidance of supine sleep via a special pillow and other measures.

Control

Position ad lib.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Positional therapy including the use of a special pillow

Avoidance of supine sleep via a special pillow and other measures.

Intervention Type: DEVICE

Other Intervention Names

Sona Pillow.

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Probable ischemic stroke within prior 14 days

Exclusion Criteria

• Any medical condition precluding the avoidance of supine posture or dictating the need for a particular position.
• Current use of CPAP (or other PAP), mechanical ventilation, or supplemental oxygen.

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

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Devin Brown

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Devin L Brown, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Svatikova A, Chervin RD, Wing JJ, Sanchez BN, Migda EM, Brown DL. Positional therapy in ischemic stroke patients with obstructive sleep apnea. Sleep Med. 2011 Mar;12(3):262-6. doi: 10.1016/j.sleep.2010.12.008.

Reference Type: RESULT

PMID: 21306949 (View on PubMed)

Other Identifiers

U024133

Identifier Type: -

Identifier Source: org_study_id