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Sleep therapy may boost heart health in older PTSD patients

NCT ID NCT05516277

Symptom relief Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a non-medication sleep program (CBT-I) can improve sleep, PTSD symptoms, and heart health in older adults with PTSD who still have sleep problems after PTSD therapy. About 167 veterans aged 50 and older will receive PTSD therapy first, then the sleep program. Researchers will measure sleep quality, PTSD severity, blood pressure, and other heart health markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-I) and Cognitive Processing Therapy (CPT)
What this could lead to
If it works, this could show that treating leftover sleep problems after PTSD therapy improves sleep, PTSD symptoms, and heart health in older adults.
What could go wrong
This is a small, early pilot study with no control group, so results may not be conclusive. Benefits might not last or apply to all older adults with PTSD.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 167 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Community-dwelling Veterans aged 50 years and older * Received care from a Veterans Health Administration (VHA) facility in the prior year * Diagnosis of PTSD * Diagnosis of insomnia disorder * Lives within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center Exclusion Criteria: * Active substance use or in recovery with less than 90 days of sobriety * Too ill to engage in the study procedures (e.g., unable to attend the in-person meetings) * Unable to self-consent to participate * Unstable housing (as this will impact the research team's ability to retrieve costly and difficult to replace monitoring equipment) * Severe cardiovascular or respiratory disease (e.g., ventilatory failure, CHF) * Unstable medical or psychiatric disorders (which are a contraindication for behavioral treatment of insomnia) * Comorbid sleep disorders (i.e., central sleep apnea syndrome, diagnosed narcolepsy or circadian rhythm sleep-wake phase disorders) based on medical record review and baseline assessment data, or untreated, severe sleep disordered breathing (SDB) as assessed via WatchPAT or previous clinical evaluation (apnea-hypopnea index \[AHI\] ≥ 30; or AHI ≥ 15 plus Epworth Sleepiness Scale \[ESS\] score ≥ 10) that better explain sleep difficulties

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder insomnia metabolic disease post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Insomnia Metabolic disease Posttraumatic stress disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • VA Greater Los Angeles Healthcare System

    RECRUITING

    North Hills, California, 91343, United States

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