Sleep Health Clinical Trial
Official title:
Sleep Health Enhancement in Midlife Adults
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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-item Acceptability Scale | 5-point Likert scales on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction | immediately post-intervention | |
Primary | Qualitative interview | semi-structured interview to assess acceptability | immediately post-intervention | |
Primary | Ru-SATED Composite score | Comprised of 6 subscores (regularity, timing, efficiency, and duration from actigraphy, satisfaction from sleep diary, and alertness from Epworth Sleepiness Scale) | baseline, Week 6, Week 12 | |
Primary | Sleep Self-Efficacy Scale | 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. | baseline, Week 6, Week 12 | |
Primary | Pittsburgh Sleep Quality Index | used to assess quality of sleep | baseline, Week 6, Week 12 | |
Primary | Epworth Sleepiness Scale | used to assess daytime sleepiness | baseline, Week 6, Week 12 | |
Primary | 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 | The DBAS-10 used to identify dysfunctional beliefs about sleep | baseline, Week 6, Week 12 | |
Primary | Positive Affect and Negative Affect Schedule | 20-item self-report questionnaire used to measure positive and negative emotions | baseline, Week 6, Week 12 | |
Primary | Continuous Performance Test | 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." | baseline, Week 6, Week 12 | |
Primary | Stroop Test | requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color) | baseline, Week 6, Week 12 | |
Primary | Cognitive Failures Questionnaire | assesses perception of cognitive abilities over the past 6 months | baseline, Week 6, Week 12 | |
Primary | Actigraphy | 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. | baseline, Week 6, Week 12 |
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