A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
Obstructive sleep apnea 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 is the most effective therapy but adherence to treatment is suboptimal. The overarching theme of the proposal is to compare usual care to Ramelteon, in a randomized, clinical trial, investigating the effectiveness of physiological versus pharmacological intervention on sleep quality of life, insomnia severity and CPAP adherence.
详细描述
Despite the overall improvement in PTSD symptomatology with CPAP therapy, adherence to CPAP is far worse in Veterans with PTSD (41%) compared to the general population with OSA (70%). Among the factors associated with CPAP non-adherence is the coexistence of insomnia. Complex insomnia defined as the coexistence of comorbid insomnia ans OSA is a frequent diagnosis in military personnel with combat exposure. Similar to prior reports of patients with OSA without PTSD, comorbid insomnia can create a barrier to CPAP therapy. Ramelteon (TAK-375), approved by the Food and Drug Administration for the treatment of insomnia with sleep onset abnormalities, is a neurohormone that functions as a melatonin receptor agonist targeting the MT1 and MT2 receptors located in the suprachiasmatic nucleus of the hypothalamus which regulates the circadian rhythm of the 24-hour sleep-wake cycle.The goal is to test the hypothesis that the administration of insomnia therapy-ramelteon- significantly improves treatment outcomes in Veterans with PTSD and complex insomnia compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤70 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)
- •CPAP non adherence defined as less than 70% of nights with >4h CPAP use despite addressing modifiable barriers for CPAP adherence
- •Psychotherapeutic treatment stable for at least 4 weeks prior to randomization
- •Capable of giving informed consent
排除标准
- •Acute or unstable chronic medical illness
- •History of narcolepsy and/or cataplexy Use of any of these medications: Fluvoxamine, fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin); fluoroquinolones including ciprofloxacin, levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), others; HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; rifampin
- •Treatment for seizure disorders
- •Pregnant or lactating
- •History of clinically significant hepatic impairment
- •History of hypersensitivity, intolerance, or contraindication to ramelteon
- •Unwilling to try or use CPAP
- •Psychiatric/Behavioral:
- •Diagnosis of current schizophrenia or schizoaffective disorder
- •Diagnosis of a substance dependence/abuse disorder in the past year
- •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
- •Receiving behavioral or pharmacological treatment for insomnia
研究组 & 干预措施
Ramelteon
Ramelteon 8 mg po at bedtime
干预措施: Ramelteon (Drug)
Usual care
education brochure about sleep hygiene
干预措施: Usual Care (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: 12 weeks post randomization
Quality of life
次要结局
- CPAP adherence(12 weeks post randomization)
- ISI(12 weeks post randomization)
- PCL-5(12 weeks post randomization)
研究者
Ali El Solh
Principal Investigator
State University of New York at Buffalo