Midlife Adults, Sleep Health
Conditions
Brief summary
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
Interventions
BEHAVIORALSleep health enhancement intervention
4 weekly visits of education and strategies to enhance sleep health
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 45-64 years old * ≤ 7 on the RU-SATED self-report questionnaire * MMSE ≥25 and AD8 \<3
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline, Week 6, Week 12 | The DBAS-10 used to identify dysfunctional beliefs about sleep |
| Positive Affect and Negative Affect Schedule | baseline, Week 6, Week 12 | 20-item self-report questionnaire used to measure positive and negative emotions |
| Continuous Performance Test | 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. |
| Stroop Test | baseline, Week 6, Week 12 | requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color) |
| 6-item Acceptability Scale | immediately post-intervention | 5-point Likert scales on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction |
| Qualitative interview | immediately post-intervention | semi-structured interview to assess acceptability |
| Ru-SATED Composite score | 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 | baseline, Week 6, Week 12 | 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. |
| Pittsburgh Sleep Quality Index | baseline, Week 6, Week 12 | used to assess quality of sleep |
| Epworth Sleepiness Scale | baseline, Week 6, Week 12 | used to assess daytime sleepiness |
| Cognitive Failures Questionnaire | baseline, Week 6, Week 12 | assesses perception of cognitive abilities over the past 6 months |
| Actigraphy | 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. |
Countries
United States
Outcome results
None listed