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NCT01920451 · ClinicalTrials.gov registry record · NA
Blood Pressure, Heart Rate Variability & Sleep in Veterans With PTSD
A NA study, sponsored by Durham VA Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT01920451 is a NA study that was terminated before completion, run by Durham VA Medical Center. The registered enrollment target is 19 participants.
The verdict
NCT01920451, a NA study, was terminated before completion, sponsored by Durham VA Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
Sleep disturbance and posttraumatic stress disorder (PTSD) are common conditions in returning Veterans, and both conditions are known to increase the risk of cardiovascular disease. Research suggests that those with insomnia are at triple the risk of high blood pressure as compared to normal sleepers, and that having both insomnia and short sleep increases this risk to more than five times that of normal sleepers. These research findings suggest that recently deployed Veterans with insomnia may be at increased risk of developing high blood pressure, and this possibility is consistent with previous research. Vietnam era Veterans with combat-related PTSD assessed in 1985 were twice as likely to have died of early-onset heart disease relative to their non-PTSD counterparts when reassessed in 2000. Evidence for impaired cardiac function in individuals with PTSD has been demonstrated across several studies as well. Compared to individuals without PTSD, those with PTSD seem to have lesser reaction to stress in terms of both heart rate and heart beat pattern. However, there has been very little research examining the impact of behavioral sleep interventions on health outcomes, and even fewer that are specific to a PTSD or Veteran population. The purpose of this study is to determine if treating insomnia results in improved blood pressure and cardiac function in recently deployed Veterans with PTSD. The findings of this research will serve as pilot data for a future grant application testing the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBTI) for reducing cardiovascular risk in Veterans with PTSD using a full-scale randomized trial design. We are hypothesizing that improved sleep will be significantly associated with improved blood pressure and increased heart rate variability (improved autonomic function) in adults receiving CBTI compared to those in a wait-list control condition.
Interventions
- BEHAVIORAL Cognitive-Behavioral Therapy for Insomnia (CBTI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01920451
The ClinicalTrials.gov registry entry for NCT01920451 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Durham VA Medical Center, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cognitive-Behavioral Therapy for Insomnia (CBTI) is the first listed.
NCT01920451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01920451 about?
NCT01920451 is a clinical study titled "Blood Pressure, Heart Rate Variability & Sleep in Veterans With PTSD". Sleep disturbance and posttraumatic stress disorder (PTSD) are common conditions in returning Veterans, and both conditions are known to increase the risk of cardiovascular disease. Research suggests that those with insomnia are at triple the risk of high blood pressure as compared to normal sleeper...
What is the current status of trial NCT01920451?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2013-08. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01920451?
The interventions under investigation include: Cognitive-Behavioral Therapy for Insomnia (CBTI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01920451?
This trial is sponsored by Durham VA Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
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