A Novel Couples- Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
The purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (OSA).
详细描述
This study will develop and test a novel couples-based intervention for the treatment of OSA and sleep health among older couples. The focus of this study is patient who are starting CPAP treatment and their partners. Couples will be randomized to a 3-session sleep health intervention delivered via telehealth or to standard educational support for CPAP. The intervention is based on a transdiagnostic model of sleep and circadian disorders (TransS-C) and rooted in the idea that older adults with OSA are often also having other sleep problems, and that OSA is best treated in the couples context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and outcomes assessors will not have knowledge of the randomization table. Participants will be reminded to not to tell the outcomes assessors their group. Only the statistician and interventionist will be aware of the group.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient and partner inclusion criteria:
- •Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention.
- •Patients inclusion criteria:
- •Diagnosed with OSA (AHI>10 or AHI>5 with impairment) and intend to start PAP treatment
- •PAP naïve or non-use of PAP for at least 3 years
- •Married or cohabiting with a romantic partner for >1 year
- •Able to read/write English.
- •Partner inclusion criteria:
- •Able to read/write English
- •PROMIS sleep disturbance score >55 in either patient or partner, or desire to improve sleep.
排除标准
- •Patient only exclusion criteria:
- •Concomitant OSA treatments (bariatric surgery planned in the next 3 months or bariatric surgery in the past year, ear nose and throat surgery for sleep apnea occurring in the 3 months before or planning for within the study period).
- •Exclusion criteria for both patient and partner include the following:
- •High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
- •History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)
- •Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the Audit-C (score >4 for men, >3 for women), drug use (NIDA-Modified ASSIST score >3)
- •Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)
- •Use of ASV, VPAP or supplemental oxygen
- •Overnight work > 1x per month
- •Pregnancy/ desire to become pregnant in the study period
- •Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years
- •Concurrent participation in another clinical trial
- •Caregiving for an infant < 2 years old or adult who requires overnight assistance.
结局指标
主要结局
Recruitment Feasibility
时间窗: study duration
Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period (12 months)
次要结局
- Percentage of Days With PAP Use of 4 Hours or More(3 months)
- Self-reported Sleep Disturbance(3 months)
研究者
Kelly Glazer Baron
Associate Professor
University of Utah