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NCT00984308: Go To Sleep

Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Completed Phase 2, PHASE3 Results posted Last updated 14 June 2017
What this trial tests

Phase 2, PHASE3 trial testing CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA) in Obstructive Sleep Apnea in 225 participants. Completed in 30 September 2011.

Timeline
23 December 2008
Primary endpoint
30 September 2011
30 September 2011

Quick facts

Lead sponsorVA Office of Research and Development
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment225
Start date23 December 2008
Primary completion30 September 2011
Estimated completion30 September 2011
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

40 and older, any sex, with Obstructive Sleep Apnea or Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sleep Apnea Diagnosis Rate Primary · The entire study period (baseline and up to one-year)

The number of patients with a diagnosis of sleep apnea

GroupValue95% CI
Intervention58
Control5
Hypertension Control Primary · One year

Medication-Adjusted Systolic Blood Pressure

GroupValue95% CI
Intervention157.4± 25
Control161.6± 24.3
Sleep Apnea Treatment Rate Secondary · One year
GroupValue95% CI
Intervention22
Control0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention
Serious: 5/110 (5%)
Deaths:
Control
Serious: 2/115 (2%)
Deaths:

Serious adverse events (5 terms)

ReactionSystemInterventionControl
Congestive heart failure (CHF)Cardiac disorders
strokeNervous system disorders
Transient ischemic attack (TIA)Nervous system disorders
DEATHGeneral disorders
Acute myocardial infarction (AMI)Cardiac disorders
Other adverse events (1 terms — click to expand)

ReactionSystemInterventionControl
FallsGeneral disorders

Most-reported serious reactions: Congestive heart failure (CHF), stroke, Transient ischemic attack (TIA), DEATH, Acute myocardial infarction (AMI).

Data from ClinicalTrials.gov NCT00984308 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Development, Validation, and Assessment of an Ischemic Stroke or Transient Ischemic Attack-Specific Prediction Tool for Obstructive Sleep Apnea.
    Sico JJ, Yaggi HK, Ofner S, Concato J, et al · · 2017 · cited 20× · PMID 28416405 · DOI 10.1016/j.jstrokecerebrovasdis.2017.03.042
  2. Diagnosis and Treatment of Sleep Apnea in patients' homes: the rationale and methods of the "GoToSleep" randomized-controlled trial.
    Bravata DM, Ferguson J, Miech EJ, Agarwal R, et al · · 2012 · cited 18× · PMID 22334806 · DOI 10.5664/jcsm.1654
  3. Diagnosing and managing sleep apnea in patients with chronic cerebrovascular disease: a randomized trial of a home-based strategy.
    Bravata DM, McClain V, Austin C, Ferguson J, et al · · 2017 · cited 17× · PMID 28386781 · DOI 10.1007/s11325-017-1494-5

Verify or expand the search:

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00984308.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing