Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack

NCT00251290 | Completed Phase 2

• 1 other identifier: RWJ-GPFS-051081
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

Brief Summary

Generalist physicians in the outpatient setting care for 80% of the 300,000 patients who have transient ischemic attacks (TIA) annually in the United States. Despite existing secondary prevention therapies, recurrent ischemic events are common following a TIA. Given the risk of poor outcomes and the important role of the generalist, new therapeutic approaches for patients with TIA are needed that can be applied by generalists to outpatients. This research will develop and evaluate a new therapeutic approach that centers on the observations that sleep-disordered breathing is a risk factor for cerebrovascular and cardiovascular disease, is common in patients with cerebrovascular disease, and is associated with poor outcome following a stroke or TIA. We posit that diagnosing and treating sleep-disordered breathing in the home of TIA patients can improve cerebrovascular and cardiovascular outcomes. The primary aims are to determine in TIA patients: 1) the prevalence of sleep-disordered breathing, 2) the feasibility of diagnosing and treating sleep-disordered breathing using an auto-titrating continuous positive airways pressure (auto-CPAP) machine within 24-hours of TIA symptom onset, 3) adherence to auto-CPAP, and 4) the effect of auto-CPAP on blood pressure. We will recruit 80 TIA patients to be randomly assigned to either the intervention or the control groups. Each patient in the intervention group will use an auto-CPAP machine for up to 90 days and will then receive an unattended sleep study using a sleep monitor. Each patient in the control group will receive two unattended sleep studies, one upon enrollment and another after 90 days.

Conditions

Transient Ischemic Attack; Sleep Apnea

Keywords

transient ischemic attack; sleep apnea

Outcome Measures

Primary Outcomes (1)

• prevalence of sleep-disordered breathing in patients with TIA, proportion of patients who use auto-CPAP >4 hours per night, and change in systolic blood pressure

  90 days

Secondary Outcomes (1)

• Recurrent vascular events (transient ischemic attack, stroke, myocardial infarction, congestive heart failure requiring hospitalization, and death), sleepiness, cognition, depression, functional status, and quality of life.

  90 days

Interventions

auto-titrating continuous positive airway pressure PROCEDURE

Continuous positive Airway pressure (CPAP) use for 90 days post TIA

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Yale University: lead
• Robert Wood Johnson Foundation: collaborator
• ResMed Foundation: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (3)

Hospital of St. Raphael

New Haven, Connecticut, 06510, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

VA Connecticut Healthcare System, West Haven Campus

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Ischemic Attack, Transient; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Dawn M Bravata, MD

  Yale School of Medicine; VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 9, 2005
• Study Start: November 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 3, 2009

Record last verified: 2009-03

Locations

US (3)