A Randomized Cross Over Trial of Two Treatments for Obstructive Sleep Apnea in Veterans With Post Traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 42
- 主要终点
- Efficacy
研究概览
简要总结
Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in patients with PTSD compared to those without PTSD and contribute to worsening cognitive and behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general population. The proposed study aims at comparing the efficacy, tolerability, and adherence of mandibular advancing devices-an alternative therapy to OSA- to CPAP. The study is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would predict MAD response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Consecutive patients aged 18-70 years of age
- •Documented obstructive sleep apnea by polysomnography (AHI≥5 or more/hr)
- •Established diagnosis of PTSD related to any past lifetime traumatic event and have a diagnosis of current, chronic PTSD
排除标准
- •• Central sleep apnea defined as central apnea/hypopnea >50% of the total respiratory events
- •Prior treatment for sleep apnea
- •Veterans with fewer than 4 teeth remaining in either arch
- •Coexisting narcolepsy
- •Tempo-mandibular joint disease
- •Prominent suicidal or homicidal ideation
- •Diagnosis of dementia
结局指标
主要结局
Efficacy
时间窗: 12 weeks
The primary objective of this trial is to assess the efficacy of MAD versus CPAP in the treatment of OSA in Veterans with PTSD.Treatment will be considered efficacious (successful) when the apnea-hypopnea index is \< 5 in the absence of hypoxemia defined as SvO2\<90%.
次要结局
- Adherence(12 weeks)
研究者
Mr. Shawn Gall
Administrative officer
The VA Western New York Healthcare System