# A pragmatic randomized comparator trial of eszopiclone and brief behavioral therapy for insomnia in CPAP non adherent Veterans with PTSD and complex insomnia

> **NIH VA I01** · VA WESTERN NEW YORK HEALTHCARE SYSTEM · 2021 · —

## Abstract

As many as 90% of Veterans with posttraumatic stress disorder (PTSD) report nightmares and
insomnia and even when nightmares are excluded, sleep disturbances are the most prevalent symptoms of
PTSD with roughly 50%-70% of patients suffering from co-occurring sleep disorders. The typical sleep
complaints include nightmares, distressed awakenings, nocturnal panic attacks, sleep terrors and insomnia.
While it has long been established that PTSD engenders sleep disturbances and averse clinical outcomes,
current investigations indicate that disordered sleep is also a risk factor for the development of PTSD.
 In military personnel with combat exposure, comorbid insomnia and OSA, a condition originally labeled
as “complex insomnia” has emerged as one of the most challenging sleep disorder to manage. In the
presence of PTSD, the co-occurrence of OSA and insomnia is also associated with significant morbidity.
Veterans with both PTSD and complex insomnia report more psychiatric symptoms, chronic pain, and higher
rates of suicide. Further, these Veterans may have more difficulty adhering to CPAP because of increased
awareness of the mask due to frequent awakenings and an inability to initiate or return to sleep with the mask
in place. Fortunately, there are effective treatments for each of these sleep disorders. Traditional treatment
models consist of treating OSA first, followed by adjunctive or concurrent treatment for insomnia only if the
response to CPAP is deemed unsatisfactory. However, the suboptimal response observed in Veterans with
PTSD from such an approach in terms of quality of life, PTSD symptoms, and CPAP adherence highlights
the need to examine alternative modalities of treatment. At present, there are no general guidelines on the
best strategy to treat complex insomnia in Veterans with PTSD.
 Prior studies have shown that cognitive behavioral therapy (CBT) is effective for treating insomnia
when compared with hypnotic agents. Whether combination therapy offers a therapeutic advantage over CBT
alone for complex insomnia in Veterans with PTSD is yet to be determined. The objective of this proposal is
to conduct a pragmatic, randomized, parallel clinical trial comparing the effectiveness of Brief Behavioral
Therapy for Insomnia in Military Veterans (BBTI-MV) plus eszopiclone, a non-benzodiazepine hypnotic,
versus BBTI-MV alone in 52 combat-exposed Veterans with PTSD and OSA with coexisting insomnia on
global sleep quality of life, PTSD symptoms, and CPAP adherence. The topic addresses several key areas
of unmet needs for Veterans with PTSD and sleep disordered breathing. Among these are: 1) the association
between complex insomnia and PTSD on global sleep quality of life; and 2) the effectiveness of combined
treatment of CBT and eszopiclone versus CBT alone in improving sleep quality and PTSD symptoms; and 3)
the impact of each treatment regimen on CPAP adherence. By establishing the most effective therapy in
alleviating insomnia that complica...

## Key facts

- **NIH application ID:** 10041697
- **Project number:** 5I01CX001656-02
- **Recipient organization:** VA WESTERN NEW YORK HEALTHCARE SYSTEM
- **Principal Investigator:** Ali A El Solh
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2021
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2019-10-01 → 2023-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10041697

## Citation

> US National Institutes of Health, RePORTER application 10041697, A pragmatic randomized comparator trial of eszopiclone and brief behavioral therapy for insomnia in CPAP non adherent Veterans with PTSD and complex insomnia (5I01CX001656-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10041697. Licensed CC0.

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