Sleep Health Enhancement in Midlife Adults

Phase 1

Recruiting

• Conditions: Sleep Health; Midlife Adults
• Interventions: Behavioral: Sleep health enhancement intervention

• Registration Number: NCT06311500
• Lead Sponsor: University of Kansas Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-12
• Study Start: 2024-02-13
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Health Enhancement Intervention	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.

Primary Outcome Measures

Name	Time	Method
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.
Epworth Sleepiness Scale	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	baseline, Week 6, Week 12	The DBAS-10 used to identify dysfunctional beliefs about sleep
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)
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."
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.
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
Pittsburgh Sleep Quality Index	baseline, Week 6, Week 12	used to assess quality of sleep
Cognitive Failures Questionnaire	baseline, Week 6, Week 12	assesses perception of cognitive abilities over the past 6 months

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States