Sleep Health Enhancement in Midlife Adults

NCT06311500 | Completed Phase 1

• 1 other identifier: STUDY00151143
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Health; Midlife Adults

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Sleep Health Enhancement Intervention

EXPERIMENTAL

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

Wait-List Control Group

NO INTERVENTION

People in the wait-list group will continue with their usual activities for 4 weeks and then start the sleep health enhancement intervention.

Interventions

Sleep health enhancement intervention BEHAVIORAL

4 weekly visits of education and strategies to enhance sleep health

Sleep Health Enhancement Intervention

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• ≤ 7 on the RU-SATED self-report questionnaire
• MMSE ≥25 and AD8 \<3

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: March 15, 2024
• Study Start: February 13, 2024
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)