Sleep Health Enhancement for Middle-Aged Adults

Overseen By Eryen Nelson, MPH

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Kansas Medical Center

Must not be taking: Sleep medications

Disqualifiers: Sleep disorders, Severe depression, Anxiety, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment Sleep Health Enhancement for Middle-Aged Adults?

Research shows that exercise training can improve sleep quality in middle-aged and older adults with sleep problems. Additionally, cognitive and behavioral interventions have been found to have a medium effect on improving sleep quality in adults without diagnosed sleep disorders. ^{1 2 3 4 5}

Is the Sleep Health Enhancement treatment safe for humans?

The available research on sleep health interventions, including behavioral and cognitive methods, suggests they are generally safe for humans, as they focus on improving sleep habits and quality without using medication. ^{4 6 7 8 9}

How is the Sleep Health Enhancement Intervention different from other treatments for sleep issues in middle-aged adults?

The Sleep Health Enhancement Intervention is unique because it combines cognitive and behavioral strategies specifically designed to improve sleep health in adults who do not have a diagnosed sleep disorder, focusing on enhancing sleep quality, duration, and timing. ^{2 3 4 5 10}

Eligibility Criteria

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

I am between 45 and 64 years old.

MMSE ≥25 and AD8 <3

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.

Trial Timeline

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

Treatment Details

Interventions

• Sleep health enhancement intervention (Behavioral 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The health-related quality-of-life impact of nocturnal awakenings in the middle-aged and older Finnish population. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Characteristics of Atypical Sleep Durations Among Older Compared to Younger Adults: Evidence from the New Zealand Health Survey. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise training improves sleep quality in middle-aged and older adults with sleep problems: a systematic review. [2022]

4. England 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. [2018]

5. Netherlands 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. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep Health Promotion Interventions and Their Effectiveness: An Umbrella Review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Japan pubmed.ncbi.nlm.nih.gov

Effect of brief sleep hygiene education for workers of an information technology company. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The National Sleep Foundation's Sleep Health Index. [2022]

10. United States 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. [2021]