Positional Therapy After Stroke

NCT01047709 | Completed Phase 2 Results

• 1 other identifier: U024133
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea Index

  Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of presumed sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The relative treatment effect on AHI using GEE modeling.

  1 day

Study Arms (2)

positional therapy

EXPERIMENTAL

Avoidance of supine positioning.

Device: Positional therapy including the use of a special pillow

Control

NO INTERVENTION

Position ad lib.

Interventions

Positional therapy including the use of a special pillow DEVICE

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

Also known as: Sona Pillow.

positional therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 21306949 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes; Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Devin Brown, MD
• Organization: University of Michigan

devinb@umich.edu

7349369075

Study Officials

• Devin L Brown, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 10, 2013
• Results First Posted: June 10, 2013

Record last verified: 2013-06

Locations

US (1)