NCT00984308

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

September 1, 2015

Completed
Last Updated

June 14, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

September 24, 2009

Results QC Date

March 31, 2015

Last Update Submit

May 15, 2017

Conditions

Obstructive Sleep ApneaStrokeTransient Ischemic AttackHypertension

Keywords

sleep apneahypertensionbrain ischemia

Outcome Measures

Primary Outcomes (2)

  • Sleep Apnea Diagnosis Rate

    The number of patients with a diagnosis of sleep apnea

    The entire study period (baseline and up to one-year)

  • Hypertension Control

    Medication-Adjusted Systolic Blood Pressure

    One year

Secondary Outcomes (1)

  • Sleep Apnea Treatment Rate

    One year

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Control

OTHER

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)

Interventions

CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)PROCEDURE

Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.

ControlIntervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke or Transient Ischemic Attack Hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (7)

  • Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.

    PMID: 22179539BACKGROUND

  • 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. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. No abstract available.

    PMID: 23283859BACKGROUND

  • 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. No abstract available.

    PMID: 23239837BACKGROUND

  • Sico JJ, Phipps MS, Yaggi HK, Burrus N, Ferguson J, McClain V, Austin C, Li X, Bravata DM. Ambulatory blood pressure monitoring among patients with cerebrovascular disease. Blood Press Monit. 2011 Oct;16(5):211-7. doi: 10.1097/MBP.0b013e32834b4d6c.

    PMID: 21885958RESULT

  • Bravata DM, Ferguson J, Miech EJ, Agarwal R, McClain V, Austin C, Struve F, Foresman B, Li X, Wang Z, Williams LS, Dallas MI, Couch CD, Sico J, Fragoso C, Matthias MS, Chumbler N, Myers J, Burrus N, Dube A, French DD, Schmid AA, Concato J, Yaggi HK. Diagnosis and Treatment of Sleep Apnea in patients' homes: the rationale and methods of the "GoToSleep" randomized-controlled trial. J Clin Sleep Med. 2012 Feb 15;8(1):27-35. doi: 10.5664/jcsm.1654.

    PMID: 22334806RESULT

  • Schmid AA, Yaggi HK, Burrus N, McClain V, Austin C, Ferguson J, Fragoso C, Sico JJ, Miech EJ, Matthias MS, Williams LS, Bravata DM. Circumstances and consequences of falls among people with chronic stroke. J Rehabil Res Dev. 2013;50(9):1277-86. doi: 10.1682/JRRD.2012.11.0215.

    PMID: 24458967RESULT

  • Zis P, Spengos K, Manios E, Vemmos K, Zis V, Dimopoulos MA, Zakopoulos N. Ambulatory blood pressure monitoring in acute stroke: the importance of time rate of blood pressure variation. Blood Press Monit. 2012 Oct;17(5):220-1; author reply 221-2. doi: 10.1097/MBP.0b013e3283588e8a. No abstract available.

    PMID: 22968110RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveStrokeIschemic Attack, TransientHypertensionSleep Apnea SyndromesBrain Ischemia

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dawn M. Bravata, MD
Organization
Department of Veterans Affairs
dawn.bravata2@va.gov
317-988-2676

Study Officials

  • Dawn M. Bravata, MD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 25, 2009

Study Start

December 23, 2008

Primary Completion

September 30, 2011

Study Completion

September 30, 2011

Last Updated

June 14, 2017

Results First Posted

September 1, 2015

Record last verified: 2017-05

Locations

US(2)