Complex Insomnia Clinical Trial
— PRECEPT-DOfficial title:
A Pragmatic Randomized Comparator Trial of Eszopiclone and Brief Behavioral Therapy for Insomnia in CPAP Non Adherent Veterans With PTSD and Complex Insomnia
| Verified date | March 2024 |
| Source | VA Office of Research and Development |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 52 |
| Est. completion date | March 30, 2025 |
| Est. primary completion date | September 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York |
| Lead Sponsor | Collaborator |
|---|---|
| VA Office of Research and Development |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | CPAP adherence | CPAP adherence will be obtained by downloading the data stored on the SmartCard. CPAP adherence will be defined as the percentage use of CPAP for 4h/night during a 28 consecutive day period. Poor adherence is denoted by <70% use of more than 4 hours per night | repeated measures between baseline and 6 months post randomization | |
| Primary | Change in Pittsburgh Sleep Quality Index (PSQI) (32) | The Pittsburgh Sleep Quality Index is a 19-item, self-rated questionnaire, assessed various aspects of sleep, sleep quality, and sleep disturbances. The PSQI is composed of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score. An overall score ranges from 0 to 21, where lower scores denote a healthier sleep quality. | repeated measures between baseline and 6 months post randomization | |
| Secondary | Change in PTSD checklist-5 (PCL-5) | PCL-5 is a 20-item self-report measures that have been widely used in military and civilian population to assess the severity of PTSD symptoms. A total symptom severity score (range 0-80) can be obtained by summing the scores from each of the 20 items that have response options from 0 "not at all" to 4 "extremely". Higher score indicates worse symptoms. | repeated measures between baseline and 6 months post randomization | |
| Secondary | Change in Insomnia Severity Index (ISI) | The ISI is a 7-item patient-reported outcome assessing the severity of initial, middle, and late insomnia; sleep satisfaction; interference of insomnia with daytime functioning; noticeability of sleep problems by others; and distress about sleep difficulties. The 5 point scale provides a score ranging from 0 to 28 with higher scores indicating more severe insomnia. | repeated measures between baseline and 6 months post randomization | |
| Secondary | Change in Beck Depression Inventory-II (BDI-II) | The BDI-II is a 21-item questionnaire in which respondents indicate on a four-point Likert-type scale (0=minimal to 3=severe) the presence and severity of depressive symptoms during the past 2 weeks. Items are scored on a 4-point scale ranging from 0 to 3, with higher scores indicating the presence of more depressive symptoms. The BDI-score ranges from 0 to 63. Higher scores indicate worse outcomes. | repeated measures between baseline and 6 months post randomization |