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Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease (Go To Sleep)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984308
First Posted: September 25, 2009
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
Sleep apnea is common among Veterans with cerebrovascular disease (stroke or transient ischemic attack [TIA]), leads to hypertension, and is associated with recurrent stroke and death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few Veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.

Condition Intervention Phase
Obstructive Sleep Apnea Stroke Transient Ischemic Attack Hypertension Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Sleep Apnea Diagnosis Rate [ Time Frame: The entire study period (baseline and up to one-year) ]
    The number of patients with a diagnosis of sleep apnea

  • Hypertension Control [ Time Frame: One year ]
    Medication-Adjusted Systolic Blood Pressure


Secondary Outcome Measures:
  • Sleep Apnea Treatment Rate [ Time Frame: One year ]

Enrollment: 225
Actual Study Start Date: December 23, 2008
Study Completion Date: September 30, 2011
Primary Completion Date: September 30, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.
Control
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.

Detailed Description:
The project sought to evaluate whether a diagnostic and therapeutic intervention strategy among Veterans with cerebrovascular disease and hypertension using unattended polysomnography and auto-titrating CPAP with a targeted adherence evaluation and educational protocol resulted in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and improved blood pressure control.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Stroke or Transient Ischemic Attack Hypertension

Exclusion Criteria:

  • Prior diagnosis of sleep apnea or other sleep disorder
  • Life expectancy < 6 months or Hospice
  • Non-English speaker
  • Unable/unwilling to use mask
  • Inability to give informed consent
  • Oxygen dependent COPD
  • Chronic renal failure with dialysis
  • Active Suicidal Ideation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984308


Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Dawn M. Bravata, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
  More Information

Publications:
Schmid AA, Yaggi HK, Burrus N, McClain V, Austin C, Ferguson J, Fragoso C, Sico J, Ofner S, Miech EJ, Matthias MS, Williams LS, Bravata DM. The Circumstances and Consequences of Post-Stroke Falls. [Abstract]. Stroke; A Journal of Cerebral Circulation. 2013 Feb 1; 44(2):TP318.
Bravata DM, Sico JJ, Phipps MS, Yaggi HK. Response to ambulatory blood pressure monitoring in acute stroke: the importance of the time rate of blood pressure variation. Blood pressure monitoring. 2012 Oct 1; 17(5):221-222.
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. Review. Erratum in: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00984308     History of Changes
Obsolete Identifiers: NCT00807417
Other Study ID Numbers: IIR 06-233
First Submitted: September 24, 2009
First Posted: September 25, 2009
Results First Submitted: March 31, 2015
Results First Posted: September 1, 2015
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
sleep apnea
hypertension
brain ischemia

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Hypertension
Apnea
Ischemic Attack, Transient
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases
Brain Ischemia
Brain Diseases
Central Nervous System Diseases