Sleep Health Enhancement for Middle-Aged Adults

Overseen By Eryen Nelson, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Kansas Medical Center

Must not be taking: Sleep medications

Disqualifiers: Sleep disorders, Severe depression, Anxiety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how improving sleep can help delay or prevent Alzheimer's disease (AD) in middle-aged adults. Participants will either join a sleep health program through weekly online sessions or be wait-listed and continue their usual activities before starting the program. The trial seeks individuals aged 45-64 who often find their sleep unrefreshing or non-restorative. Those with untreated sleep disorders or severe mental health issues are not eligible. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking Alzheimer's prevention strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you regularly use medications to improve sleep more than twice a week.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that methods to improve sleep are generally safe for most people. Previous studies have examined non-drug approaches to enhance sleep in healthy individuals, often focusing on teaching sleep improvement techniques.

Participants typically experience better sleep and overall health, with no major safety concerns. These treatments frequently lead to improved sleep and health without serious side effects.

In early-stage studies (Phase 1 or Phase 2), researchers closely monitor safety. While the treatment is expected to be safe, they continue to gather detailed safety information. Overall, these methods are considered a promising and safe way to improve sleep. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the sleep health enhancement intervention because it offers a fresh approach to improving sleep without relying on medication. Unlike standard treatments like sleep medications or cognitive behavioral therapy for insomnia, this intervention uses a series of educational sessions via Zoom to teach strategies for better sleep. This method is non-invasive, easy to access, and focuses on long-term lifestyle changes, which may help people manage their sleep health more sustainably.

What evidence suggests that this sleep health enhancement intervention could be effective for improving sleep in middle-aged adults?

Research shows that improving sleep habits can enhance sleep quality, particularly for middle-aged or older individuals. This trial will evaluate the Sleep Health Enhancement Intervention, which includes education and strategies to improve sleep health. Studies have found that increasing sleep duration benefits those who lack sufficient rest. Simple changes in sleep behavior have improved sleep and reduced pain for middle-aged adults. Additionally, exercise programs targeting better sleep have successfully helped older adults sleep more soundly. These findings suggest that a comprehensive sleep program could significantly improve sleep for middle-aged adults and might even help delay Alzheimer's disease. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for mid-life adults aged 45-64 who are interested in improving their sleep health as a way to potentially prevent Alzheimer's disease. The study will develop and test the feasibility of a comprehensive sleep health intervention.

Inclusion Criteria

≤ 7 on the RU-SATED self-report questionnaire

MMSE ≥25 and AD8 <3

I am between 45 and 64 years old.

Exclusion Criteria

Current or history (within 5 years) of shift work including hours of midnight-4am

Evidence of parasomnia

I have a history of conditions like stroke or Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Wait-List Control

Participants in the wait-list group will continue with their usual activities for 4 weeks before starting the sleep health enhancement intervention

4 weeks

Sleep Health Enhancement Intervention

4 weekly visits using Zoom video conferencing consisting of education and strategies to enhance sleep health

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for sleep quality and cognitive performance post-intervention

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep health enhancement intervention

Trial Overview The trial is testing a new program designed to enhance sleep quality among middle-aged adults. Participants will undergo this Sleep Health Intervention (SHI) with the goal of assessing its effectiveness, acceptability, and practicality.

How Is the Trial Designed?

Group I: Sleep Health Enhancement Intervention Experimental Treatment 1 Intervention

4 weekly visits using Zoom video conferencing consisting of education and strategies to enhance sleep health with each visit lasting about 60 minutes.

Group II: Wait-List Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

This meta-analysis of 11 studies involving adults aged 18-64 without diagnosed sleep disorders found that cognitive and behavioral interventions significantly improve sleep quality, with a medium effect size (Hedge's g = -0.54).

The most effective interventions included components like stress management, relaxation practices, stimulus control, sleep hygiene, and exercise, highlighting the importance of self-regulation techniques in enhancing sleep health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of cognitive and behavioral interventions to improve sleep health in adults without sleep disorders. Murawski, B., Wade, L., Plotnikoff, RC., et al.[2018]

Frequent nocturnal awakenings significantly decrease health-related quality of life (HRQOL) in Finnish individuals aged 55-75, with a notable adjusted HRQOL impact of -0.0416.

Both insufficient sleep (less than 6.5 hours) and excessive sleep (more than 10 hours) are linked to a higher likelihood of low HRQOL, indicating that sleep duration also plays a critical role in overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The health-related quality-of-life impact of nocturnal awakenings in the middle-aged and older Finnish population. Väätäinen, S., Tuomilehto, H., Saramies, J., et al.[2021]

In a study of 40,659 adults, including 24.2% older adults (aged 65 and above), it was found that atypical sleep patterns (short or long sleep) were less common in older adults compared to younger adults, with only 3.0% experiencing short sleep and 7.4% long sleep.

Atypical sleep in older adults was linked to poorer physical and mental health, as indicated by lower SF-12 scores, and having three or more health conditions was specifically associated with short sleep, highlighting the importance of addressing health factors in managing sleep issues in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Atypical Sleep Durations Among Older Compared to Younger Adults: Evidence from the New Zealand Health Survey. Gibson, R., Akter, T., Jones, C., et al.[2023]

This umbrella review analyzed 35 systematic reviews and meta-analyses to evaluate non-pharmacological sleep health interventions in primarily healthy populations, highlighting effective strategies such as later school start times, behavior change methods, and mind-body exercises.

While some interventions like sleep education and relaxation techniques showed potential benefits for sleep quality, the evidence was less consistent, indicating a need for further research to solidify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Health Promotion Interventions and Their Effectiveness: An Umbrella Review. Albakri, U., Drotos, E., Meertens, R.[2021]

A systematic review of six trials involving 305 middle-aged and older adults showed that exercise training programs significantly improve sleep quality, as measured by the Pittsburgh Sleep Quality Index, with a moderate effect size (SMD of 0.47).

Participants in the exercise group experienced reduced sleep latency and decreased medication use for sleep issues, suggesting that physical exercise can be an effective alternative or complement to traditional sleep therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training improves sleep quality in middle-aged and older adults with sleep problems: a systematic review. Yang, PY., Ho, KH., Chen, HC., et al.[2022]

A study of 41,094 middle-aged adults identified three sleep trajectories: healthy sleepers, borderline poor sleepers, and poor sleepers, with 27.6% classified as poor sleepers, indicating that sleep issues can be persistent rather than temporary.

Key risk factors for poor sleep included socio-economic disadvantage, ethnic minority background, and depressive symptoms, with about one-third of the impact of socio-economic deprivation on sleep mediated by depression, suggesting that addressing mental health could improve sleep outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep trajectories and mediators of poor sleep: findings from the longitudinal analysis of 41,094 participants of the UK Biobank cohort. Fatima, Y., Bucks, RS., Mamun, AA., et al.[2021]

A one-hour sleep hygiene education program for 581 IT workers led to a significant reduction in afternoon sleepiness, as measured by the Karolinska Sleepiness Scale, with a notable effect size of 0.50.

While the program improved afternoon alertness, it did not show a statistically significant impact on overall sleep quality at night, as assessed by the Pittsburgh Sleep Quality Index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of brief sleep hygiene education for workers of an information technology company. Kakinuma, M., Takahashi, M., Kato, N., et al.[2022]

In a study of 300 midlife women over 12 years, sleep duration actually increased, and wake after sleep onset (WASO) decreased, suggesting that sleep may not worsen as women age through menopause.

The study found that Black and white women experienced a greater increase in sleep duration compared to Chinese women, indicating that racial and cultural factors may influence sleep patterns during midlife.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does midlife aging impact women's sleep duration, continuity, and timing?: A longitudinal analysis from the Study of Women's Health Across the Nation. Matthews, KA., Kravitz, HM., Lee, L., et al.[2021]

The Sleep Health Index (SHI) is a validated 28-question survey developed to assess sleep health in adults, demonstrating reliability in measuring sleep quality, duration, and disorders based on data from 2,503 participants across the U.S.

The average SHI score for Americans was 76/100, with sleep quality being the lowest sub-index score at 68/100, indicating that self-reported stress and overall health are significant predictors of sleep health and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National Sleep Foundation's Sleep Health Index. Knutson, KL., Phelan, J., Paskow, MJ., et al.[2022]

A national project in Japan highlighted the importance of sleep for elderly health, revealing that short naps and moderate evening exercise can significantly improve sleep quality and mental health in older adults.

After a 4-week intervention involving short naps and exercise, participants experienced decreased wake time after sleep onset and improved sleep efficiency, leading to better overall quality of life and daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep health, lifestyle and mental health in the Japanese elderly: ensuring sleep to promote a healthy brain and mind. Tanaka, H., Shirakawa, S.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8196727/

Sleep Health Promotion Interventions and Their Effectiveness The aim of this umbrella review is to determine what non-pharmacological sleep health interventions have been evaluated among healthy populations.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945725002400

Development of a culturally tailored sleep intervention for ... This study provides practical strategies for developing tailored sleep interventions for midlife AAW.

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9476

Sleep is essential to health - Journal of Clinical Sleep Medicine Emerging data suggest that extending the nightly sleep duration of people who habitually get insufficient sleep is associated with health benefits. Healthy ...

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1529519/full

The effectiveness of exercise interventions in ... Exercise interventions have demonstrated positive effects on enhancing sleep quality among the older adult population.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6377323/

Improving pain and sleep in middle-aged and older adults Behavioral sleep interventions are a promising avenue for providing better and safer sleep and pain outcomes for middle-aged and older adults.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171441830288X

A randomised controlled trial to test the efficacy of an m- ... This study aims to examine the efficacy of a combined physical activity and sleep intervention to improve sleep quality in middle-aged adults.

7. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-sleep-health-enhancement-midlife-adults-trial-nct06311500

Sleep Health Enhancement in Midlife Adults Participants may experience improved sleep quality, better overall health, and a potential reduction in the risk of developing Alzheimer's disease later in life ...

8. nature.com nature.com/articles/s41398-024-02875-2

Exercise intervention in middle-aged and elderly ... The aim of the study is to identify the effects of a 12-week exercise program on sleep quality and brain functional connectivity in middle-aged and older ...