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Completed

NCT Number: NCT06311500

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

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Key information

Conditions

Sleep Health Midlife Adults

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Health Enhancement Intervention

Behavioral

4 weekly visits of education and strategies to enhance sleep health

Primary outcomes

  1. 6-item Acceptability Scale

    Time frame: immediately post-intervention

    5-point Likert scales on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction

  2. Qualitative interview

    Time frame: immediately post-intervention

    semi-structured interview to assess acceptability

  3. Ru-SATED Composite score

    Time frame: 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)

  4. Sleep Self-Efficacy Scale

    Time frame: baseline, Week 6, Week 12

    9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy.

  5. Pittsburgh Sleep Quality Index

    Time frame: baseline, Week 6, Week 12

    used to assess quality of sleep

  6. Epworth Sleepiness Scale

    Time frame: baseline, Week 6, Week 12

    used to assess daytime sleepiness

  7. 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

    Time frame: baseline, Week 6, Week 12

    The DBAS-10 used to identify dysfunctional beliefs about sleep

  8. Positive Affect and Negative Affect Schedule

    Time frame: baseline, Week 6, Week 12

    20-item self-report questionnaire used to measure positive and negative emotions

  9. Continuous Performance Test

    Time frame: 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."

  10. Stroop Test

    Time frame: baseline, Week 6, Week 12

    requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color)

  11. Cognitive Failures Questionnaire

    Time frame: baseline, Week 6, Week 12

    assesses perception of cognitive abilities over the past 6 months

  12. Actigraphy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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