Improving Sleep Apnea Treatment Adherence after Brain Injury: A Feasibility Study

提高脑损伤后睡眠呼吸暂停治疗的依从性：可行性研究

• 批准号: 10009888
• 负责人: Marc A. Silva
• 金额: --
• 依托单位: JAMES A. HALEY VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009888
• 关键词: Address; Adherence; Admission activity; Anoxia; Behavior Therapy; Brain; Brain Injuries; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinic; Clinical; Clinical Research; Cognition; Cognitive; Cognitive Therapy; Communities; Computer software; Consent; Control Groups; Cost Savings; Data; Dementia; Devices; Diagnosis; Disease; Eligibility Determination; Enrollment; Evidence based intervention; Feasibility Studies; Future; General Population; Goals; Health; Health Care Costs; Hospitals; Impaired cognition; Individual; Informed Consent; Inpatients; Intervention; Interview; Measures; Medical; Mental Health; Methods; Military Personnel; Monitor; Neurologic; Obstructive Sleep Apnea; Outcome; Outcome Measure; Outpatients; Participant; Persons; Population; Premature Mortality; Process Measure; Protocols documentation; Psyche structure; Quality of life; Randomized; Recommendation; Rehabilitation Outcome; Reporting; Research; Research Priority; Risk; Risk Factors; Series; Severities; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Societies; Specific qualifier value; Stroke; Symptoms; Testing; Therapeutic; Traumatic Brain Injury; United States Agency for Healthcare Research and Quality; United States National Institutes of Health; Veterans; Veterans Hospitals; adverse outcome; base; brain health; comorbidity; control trial; dementia risk; design; disability; efficacy testing; evidence base; high risk; improved; injury prevention; innovation; meetings; mild cognitive impairment; modifiable risk; mortality; motivational enhancement therapy; neurological rehabilitation; novel; outcome prediction; physical conditioning; post intervention; premature; pressure; programs; protective factors; psychoeducation; psychoeducational; recruit; sleep quality; standard of care; success; therapy design; treatment adherence; treatment as usual

Background: Obstructive sleep apnea (OSA) is a sleep disorder that commonly occurs in Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental health, poor physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces the many negative health consequences of the disease. However, adherence to PAP is required to reap the therapeutic benefit. Unfortunately, PAP adherence is poor. Our recent study showed that 68% of Veterans with moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is part of the standard of care for OSA treatment with PAP, but on its own is insufficient for improving PAP adherence. Alternatives to the standard of care include evidence-based behavioral interventions such as Motivational Interviewing (MI) and Cognitive- Behavioral Therapy (CBT) which have been shown to increase PAP use and improve PAP adherence in persons without TBI. Unfortunately, these evidence-based interventions (designed for cognitively intact individuals) have not been adapted to address PAP adherence in persons with moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is to test the feasibility of a novel 4-session manualized intervention, designed with cognitive accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and OSA. Study Aims: Study Aim 1 will test the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 will evaluate the feasibility of outcome and process measures. To date, no treatment exists to ameliorate the adverse consequences of moderate-to-severe TBI. OSA is a treatable health condition that commonly co-occurs with TBI, which is a leading cause of long-term disability. Method: We will recruit 19 Veterans from inpatient and outpatient TBI and sleep clinics at this hospital. Those meeting eligibility criteria (diagnosis of OSA and moderate-to- severe TBI; nonadherent to PAP, able to provide informed consent) will be invited to participate in the 4-session intervention followed by a qualitative interview to inquire about intervention acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be administered pre- and post-intervention. Adherence will be measures via objective data from hospital software which monitors PAP use. Expected Outcomes and Significance: This innovative study will be the first to develop, test, and refine a clinical intervention designed to enhance PAP adherence using cognitive accommodations specifically for persons with moderate-to-severe TBI. If the intervention is shown to be feasible, results from this study will be used to refine the intervention, and in a future randomized control trial, test the efficacy of the adapted intervention versus treatment as usual in improving adherence (and subsequently the impact on TBI rehabilitation outcomes). The long-term goal is to develop a program of research aimed at improving rehabilitation outcomes in Veterans and Military personnel with TBI by developing, testing, and distributing interventions to enhance the success of front-line treatments for OSA and reduce or eliminate the negative consequences of OSA in the context of moderate-to-severe TBI.

背景：阻塞性睡眠呼吸暂停（OSA）是一种常见于退伍军人的睡眠障碍 中度至重度创伤性脑损伤（TBI）。未经治疗的OSA增加了健康状况不佳的风险 结果包括认知障碍、心理健康状况下降、身体健康状况不佳，以及 过早死亡气道正压通气（PAP）是OSA的一线治疗方法， 有效地减少了疾病对健康的许多负面影响。然而，坚持 PAP需要获得治疗益处。不幸的是，PAP的依从性很差。我们最近 研究表明，68%患有中重度TBI和OSA的退伍军人不遵守 PAP疗法。心理教育是PAP治疗OSA的标准护理的一部分， 其自身不足以改善PAP依从性。标准护理的替代方案包括 基于证据的行为干预，如动机性访谈（MI）和认知- 行为疗法（CBT）已被证明可以增加PAP的使用并改善PAP 在没有TBI的人中坚持。不幸的是，这些基于证据的干预措施（专为 认知完整的个体）尚未适应于解决患有以下疾病的人的PAP依从性： 中度至重度TBI，他们通常需要认知调节。本研究的目的是 测试一种新的4节手动干预的可行性，设计与认知 住宿，并由MI和CBT通知，以解决TBI退伍军人的PAP依从性 和OSA。研究目的：研究目的1将测试输送PAP的可行性和可接受性 坚持干预。研究目标2将评价结果和过程措施的可行性。 到目前为止，还没有治疗方法来改善中度至重度TBI的不良后果。 OSA是一种可治疗的健康状况，通常与TBI同时发生，TBI是导致OSA的主要原因。 长期残疾。方法：我们将从住院和门诊TBI中招募19名退伍军人， 在这家医院的睡眠诊所符合资格标准（诊断为OSA和中度至中度 严重TBI;不遵守PAP，能够提供知情同意书）将被邀请参加 4次干预，然后进行定性访谈，询问干预情况 可接受性研究措施（例如，症状严重程度、睡眠生活质量）， 干预前后。依从性将通过医院软件的客观数据进行测量 监测PAP的使用。预期成果和意义：这项创新性研究将 第一个开发、测试和完善旨在提高PAP依从性的临床干预措施的公司 使用专门针对中度至重度TBI患者的认知调节。如果 干预被证明是可行的，本研究的结果将用于完善干预， 在未来的随机对照试验中，测试适应性干预与 在提高依从性方面（以及随后对TBI康复的影响） 成果）。长期目标是制定一项旨在改善 通过开发、测试和 分发干预措施，以提高OSA一线治疗的成功率， 在中度至重度TBI的背景下消除OSA的负面后果。