Sleep therapy may protect hearts of PTSD patients
NCT ID NCT04498754
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether treating insomnia can reduce the risk of heart disease in people with PTSD. Researchers measured blood pressure, blood vessel health, and other heart risk factors in 140 adults aged 40-59. The goal was to see if improving sleep could also improve heart health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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140 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 59 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Is between 40-59 years old; * Has a current diagnosis of chronic PTSD (at least 3 months duration) based on the Clinician Administered PTSD Scale DSM-5 version (Weathers et al., 2013); * Has a current diagnosis of ID as defined in the International Classification of Sleep Disorders (ICSD-3; American Academy of Sleep Medicine, 2014) Exclusion Criteria: * Has a history of CVD events, including myocardial infarction, stroke, transient ischemic attack, or coronary revascularization; * Has diagnosis of congestive heart failure or coronary artery disease based on results of diagnostic testing; * Has a current alcohol use or substance use disorder (those who meet lifetime but not current alcohol or substance use disorder will be included); * Is currently participating in or has recently (past 6 months) participated in an evidence-based trauma focused therapy for PTSD; * Has cognitive impairment as evidenced by less than 20 on the Montreal Cognitive Assessment scale (M0CA; Nasreddine et al., 2005); * Meets criteria for a psychotic spectrum disorder or bipolar disorder; * Has severely impaired hearing or speech; * Is pregnant; * Does not use benzodiazepines for sleep, and if prescribed benzodiazepines for some other use (e.g., anxiety, panic attacks), uses them fewer than four times in a one month period.; * Is not stable (medications and dose stable for one month) on any other current psychoactive and/or cardiovascular medications or will not be stable on these medications during the course of the study; * Works night shift; * Is participating in another interventional study to address insomnia; * Has prominent suicidal or homicidal ideation (as assessed through a clinical interview); * Has a serious/terminal illness or other health problem that would prohibit participation in the study; * Has nonclinically significant or sub-threshold insomnia as indicated by a score of \<8 on the Insomnia Severity Index; * Has seizures (based on clinical interview and self-report); * Has a body mass index of 45 or greater; * Has sleep apnea (based on the overnight assessment described below) or a positive sleep apnea screen; * Has restless leg syndrome (based on the Duke Structured Interview for Sleep Disorders (DSISD); Edinger, Wyatt, \& Olsen, 2009), and that sleep disorder is the primary cause of their sleep complaint (participants with restless legs syndrome who also have insomnia disorder can be included in the study); * Has an organic cause of sleep disruption that cannot be addressed by cognitive-behavioral changes (e.g., hyperthyroidism), as determined by the DSISD; * Has excessive daytime sleepiness, defined as a score \>15 on the Epworth Sleepiness Scale (ESS) or as determined by the DSISD; * Does not complete sleep diary assessments within 6 hours of rising on at least 5 of the 7 days of the initial assessment period; or * Cancels or no-shows for two or more Time 1 assessment appointments * Has uncontrolled hypertension (screening office BP \> 160/100 mm Hg)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27706, United States
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Other studies related to the condition(s) this trial covers.
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