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

Study Overview

• Status: Completed
• Conditions: Sleep Health; Midlife Adults
• Intervention / Treatment: Behavioral: Sleep health enhancement intervention

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Sleep health enhancement intervention; 4 weekly visits of education and strategies to enhance sleep health
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-item Acceptability Scale	5-point Likert scales on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction	immediately post-intervention
Qualitative interview	semi-structured interview to assess acceptability	immediately post-intervention
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
Sleep Self-Efficacy Scale	9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy.	baseline, Week 6, Week 12
Pittsburgh Sleep Quality Index	used to assess quality of sleep	baseline, Week 6, Week 12
Epworth Sleepiness Scale	used to assess daytime sleepiness	baseline, Week 6, Week 12
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
Positive Affect and Negative Affect Schedule	20-item self-report questionnaire used to measure positive and negative emotions	baseline, Week 6, Week 12
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
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
Cognitive Failures Questionnaire	assesses perception of cognitive abilities over the past 6 months	baseline, Week 6, Week 12
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Actual): November 19, 2025
• Study Completion (Actual): November 19, 2025

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00151143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No