Sleep Health Enhancement in Midlife Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Ru-SATED Composite score
研究概览
简要总结
Despite the strong links between sleep and AD, a sleep health enhancement has yet to be targeted in mid-life adults (45-64 years old) to delay or prevent AD. An intervention aimed at enhancing sleep health is a critical opportunity for primary prevention to potentially delay the onset of AD. The objective of the proposed study is to develop and assess the feasibility, acceptability, and treatment effect of a comprehensive sleep health intervention (SHI) on improving sleep health in mid-life adults
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •45-64 years old
- •≤ 7 on the RU-SATED self-report questionnaire
- •MMSE ≥25 and AD8 <3
排除标准
- •Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- •>3 on the STOP BANG indicating increased risk of sleep apnea
- •Increased risk of restless legs syndrome on RLS-Diagnosis Index
- •Evidence of circadian rhythm sleep-wake disorder
- •Evidence of parasomnia
- •Regular use (>2x/week) of prescription or over-the-counter medications to improve sleep
- •Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- •Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety
- •Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-5-TR criteria
- •History of nervous system disorder such as stroke or Parkinson's disease
- •Severe mental illness such as schizophrenia or bipolar disorder
- •Current or history (within 5 years) of shift work including hours of midnight-4am
- •Is currently receiving a behavioral sleep health intervention
研究组 & 干预措施
Sleep Health Enhancement Intervention
4 weekly visits using Zoom video conferencing consisting of education and strategies to enhance sleep health with each visit lasting about 60 minutes.
干预措施: Sleep health enhancement intervention (Behavioral)
Wait-List Control Group
People in the wait-list group will continue with their usual activities for 4 weeks and then start the sleep health enhancement intervention.
结局指标
主要结局
Ru-SATED Composite score
时间窗: baseline, Week 6, Week 12
Comprised of 6 subscores (regularity, timing, efficiency, and duration from actigraphy, satisfaction from sleep diary, and alertness from Epworth Sleepiness Scale)
Sleep Self-Efficacy Scale
时间窗: baseline, Week 6, Week 12
9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy.
Epworth Sleepiness Scale
时间窗: baseline, Week 6, Week 12
used to assess daytime sleepiness
Dysfunctional Beliefs About Sleep (DBAS-10) consists of 10 statements reflecting beliefs and attitudes about sleep. Each statement is rated from 1 = strongly disagree to 10 = strongly agree
时间窗: baseline, Week 6, Week 12
The DBAS-10 used to identify dysfunctional beliefs about sleep
Stroop Test
时间窗: baseline, Week 6, Week 12
requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color)
Positive Affect and Negative Affect Schedule
时间窗: baseline, Week 6, Week 12
20-item self-report questionnaire used to measure positive and negative emotions
Continuous Performance Test
时间窗: baseline, Week 6, Week 12
requires participants to respond as quickly and accurately as possible to a series of stimuli that are delivered via computer. The participants will be instructed to tap the space bar for every letter except "X."
Actigraphy
时间窗: baseline, Week 6, Week 12
Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration.
6-item Acceptability Scale
时间窗: immediately post-intervention
5-point Likert scales on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
Qualitative interview
时间窗: immediately post-intervention
semi-structured interview to assess acceptability
Pittsburgh Sleep Quality Index
时间窗: baseline, Week 6, Week 12
used to assess quality of sleep
Cognitive Failures Questionnaire
时间窗: baseline, Week 6, Week 12
assesses perception of cognitive abilities over the past 6 months
次要结局
未报告次要终点