Helping Veterans With Obstructive Sleep Apnea Determine What Matters Most in Choosing a Treatment Option: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Previous studies have shown that programs encouraging the use of OSA treatments can help patients use these treatments more often, but the improvement is usually modest. This trial will test if giving patients a decision-making tool when they are first diagnosed with OSA, and combining their responses from this tool into a supportive program, will improve sleep quality and help them use their treatment more regularly.
详细描述
Background and Significance:
Obstructive Sleep Apnea (OSA) is a significant health issue for many middle-aged and older Veterans. This condition can lead to daytime sleepiness and poor sleep quality and is a risk factor for more serious conditions such as cardiovascular disease, cognitive decline, and even increased risk of death. Common treatments for OSA include the use of medical devices such as positive airway pressure machines or oral appliances. However, many Veterans find these devices uncomfortable or difficult to use regularly. This clinical trial aims to test a new 4 session program to help Veterans stick to their OSA treatment plans using a more person-centered approach.
Innovation and Impact:
This innovative, person-centered approach is integral to the VA's "age-friendly" healthcare transformation. By focusing on what matters most to older Veterans, the investigators aim to enhance their compliance with, and the effectiveness of, OSA therapy. Aligning OSA treatment decisions with each Veteran's health priorities is expected to improve their overall wellbeing and make OSA treatments more effective.
Specific Aims:
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, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group assignment.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period
- •currently untreated for OSA (not prescribed therapy in the past year)
排除标准
- •referral for overnight sleep test is for another reason than to diagnosis sleep-disordered breathing
- •unable to read printed material (e.g., magazine) in English language
- •unable to write
- •unstable medical/psychiatric illness (e.g., recent hospitalization)
- •Telephone Mini-Mental State Examination (MMSE) < 21 or diagnosis of dementia
- •unstable housing
- •unable to attend study video or in-person visits
研究组 & 干预措施
Sleep education program X + Y
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests behavioral strategy program X plus Y.
干预措施: Behavioral strategy program X plus Y (Behavioral)
Sleep education program X
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.
干预措施: Behavioral strategy program X (Behavioral)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
The PSQI total score will be used as a measurement of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
次要结局
- Treatment adherence by machine report(6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.)
- Acceptance of therapy(One week after the end of the intervention/control sessions, which is approximately 2 months after randomization.)