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New combo approach targets insomnia in veterans with PTSD

NCT ID NCT03937713

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding the sleep medication eszopiclone (Lunesta) to brief behavioral therapy improves sleep quality and CPAP use in veterans with PTSD and complex insomnia. Fifty-three veterans who had trouble sticking with CPAP therapy for sleep apnea took part. The goal was to see if the combination helps them sleep better and manage PTSD symptoms.

What this could mean

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

Active substance
eszopiclone (Lunesta)
What this could lead to
If successful, this could point toward a better way to improve sleep and CPAP use in veterans with PTSD and insomnia.
What could go wrong
This is a small, completed Phase 4 trial with only 53 participants, so results may not apply broadly. The drug eszopiclone can cause side effects like drowsiness or dizziness.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

53 people

The number who actually took part.

Started

Dec 2019

Finished

Mar 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>18 years and \<65 years old * Diagnosis of PTSD as determined by the intake conducted through the PTSD Clinic or the Mental Health Clinic * Documented obstructive sleep apnea by polysomnography (AHI 5 or more/hour) who are non-adherent to CPAP as defined by device usage of less than 4 hours per night * Chronic ( 3 months' duration) insomnia disorder * Psychotherapeutic treatment stable for at least 4 weeks prior to randomization * Capable of giving informed consent Exclusion Criteria: * Insomnia secondary to pain * History of narcolepsy and/or cataplexy * Treatment for seizure disorders * Pregnant or lactating * History of clinically significant hepatic impairment * History of hypersensitivity, intolerance, or contraindication to eszopiclone * Use of potent cytochrome p450 3A4 inhibitor medications (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication * Unwilling to try or use CPAP * Diagnosis of current schizophrenia or schizoaffective disorder * Diagnosis of a substance dependence/abuse disorder in the past year * History of complex nocturnal behaviors while using eszopiclone * Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others * Diagnosis of bipolar disorder * Consumption of more than two alcoholic beverages per night * Documented or self-reported resolution of insomnia from current behavioral or pharmacological treatment of insomnia

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Conditions

The condition(s) this trial relates to.

insomnia obstructive sleep apnea syndrome post-traumatic stress disorder

As listed by the trial registrant

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

Complex insomnia

Contacts and locations

Locations

  • VA Western New York Healthcare System, Buffalo, NY

    Buffalo, New York, 14215-1129, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.