A Pragmatic Randomized Comparator Trial of Eszopiclone and Brief Behavioral Therapy for Insomnia in CPAP Non Adherent Veterans With PTSD and Complex Insomnia

NURB-008-18F

Obstructive sleep apnea (OSA) is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure (CPAP) is the most effective therapy but adherence to treatment is suboptimal. Insomnia is considered a barrier to long-term adherence. The overarching theme of the proposal is to compare the effectiveness of cognitive behavioral therapy for insomnia (CBT) plus eszopiclone, a nonbenzodiazepine hypnotic, versus CBT alone in Veterans with PTSD who are diagnosed with both OSA and insomnia, using a randomized, clinical trial, on sleep quality of life, PTSD severity, and CPAP adherence.

2019-12-01

2024-09-30

2025-03-30

Active (not recruiting)

Early phase I

52

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized comparator 1:1 to explore the comparative effectiveness of combination treatment of behavioral and pharmacological interventions with behavioral therapy alone in improving sleep quality of life, Veterans with PTSD and complex insomnia.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}

2024-03-22