Sleep Apnea Treatment After Stroke (SATS)

Stroke Clinical Trial

Official title:

Treatment of Obstructive Sleep Apnea After Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00282815
• Other study ID #: K23NS051202
• Status: Terminated
• Phase: Phase 2
• First received: January 26, 2006
• Last updated: January 31, 2013
• Start date: September 2004
• Est. completion date: May 2010

Study information

• Verified date: December 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.

Description:

Stroke is the leading cause of adult disability in the United States, yet there are very few treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper airway blockage that occurs during sleep--is common after stroke, affecting more than half of stroke patients. The most common treatment for obstructive sleep apnea in the general population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.

The objective of this single-center, prospective, randomized study is to evaluate CPAP treatment in post-stroke patients. Participants will go through a medical interview, a brief neurological examination, and a sleep study to screen them for OSA. Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP (placebo).

This project promises to establish feasibility, develop design and identify suitable outcome measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue, and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all stroke patients will become available.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ischemic stroke within 7 days of planned polysomnography/sleep screening study

• Modified Rankin Scale score >1

• If of child-bearing potential, has a negative urine or serum pregnancy test

Exclusion Criteria:

• Decompensated heart failure

• Cardiac or respiratory arrest within the past 3 months

• Myocardial infarction within the past 3 months

• Severe pneumonia

• Hypertension refractory to treatment

• Any other unstable medical condition which is thought to interfere with participation

• Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP

• Previous pneumothorax

• Bullous emphysema

• Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP

• Acute sinus or ear infection

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke

Intervention

Device:
• continuous positive airway pressure or CPAP
RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
• sham CPAP
sham CPAP

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.		3 months	No
Primary	Number of Subjects Who Withdraw From Study.	Prespecified outcome.	3 months	No
Secondary	Barthel Index	Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).	3 months	No