Sleep Health Education for Insomnia

(SWELL24 Trial)

Overseen By Laura Welti

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Sleep apnea, Terminal illness, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how education and coaching on healthy nighttime sleep and daytime activity behaviors can help frail older adults with insomnia improve their sleep and daily activity. Participants will attend four in-person sessions with a trained provider to learn about healthy sleep and activity habits. As a pilot study, researchers aim to test the practicality and acceptability of this approach. The trial seeks individuals aged 65 or older who have been diagnosed with insomnia and have low levels of physical activity. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep and activity habits for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this education and coaching intervention is safe for frail older adults?

Research has shown that learning about healthy sleep habits is generally safe. In past studies, participants who received sleep health education reported better sleep. For example, one study found a 20% decrease in the number of people with poor sleep quality after the program. Another study noted that half of the participants in the sleep education group experienced improved sleep.

These studies did not report any serious issues or negative effects from the education and coaching. This suggests that learning how to improve sleep habits is usually well-tolerated. Teaching better habits typically doesn't cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this sleep health education and coaching program for insomnia because it offers a personalized, holistic approach that goes beyond traditional treatments like medication or cognitive behavioral therapy. This program focuses on empowering individuals to develop sustainable, healthy sleep and activity habits through a series of in-person sessions with a Master's-level provider. Unlike standard treatments that might focus solely on nighttime sleep, this program emphasizes the importance of both nighttime and daytime behaviors, aiming to create a more comprehensive lifestyle change for better sleep health.

What evidence suggests that education and coaching on developing healthy nighttime sleep and daytime activity behaviors is effective for insomnia?

Research shows that learning about sleep and receiving guidance on daily activities can enhance sleep quality. One study demonstrated that educating people about sleep health reduced reports of poor sleep, with only 50% of participants reporting poor sleep afterward. Another study found that sleep coaching improved both perceptions of sleep and actual sleep measurements, while also reducing daytime tiredness. However, learning about good sleep habits alone might not suffice to treat insomnia, as evidence remains insufficient. Overall, combining education with coaching, which participants in this trial will receive, appears promising for improving sleep. ^{1 2 6 7 8}

Who Is on the Research Team?

Jaime M Hughes, PhD, MPH, MSW

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

The SWELL24 trial is for adults over 65 who have insomnia, can follow instructions, and have had a primary care visit at Wake Forest Baptist Health in the past year. They should be physically inactive but able to walk safely with or without help. Those with serious medical conditions, untreated sleep disorders like sleep apnea or restless leg syndrome, substance abuse issues, or living in institutional care cannot join.

Inclusion Criteria

English speaking

I can walk safely on my own or with help.

I am 65 years old or older.

Exclusion Criteria

I have not been treated for any sleep disorders like sleep apnea or restless leg syndrome.

My medical records show I cannot make my own health decisions.

Referred to institutional care and/or currently residing in a nursing home or other residential facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive education and coaching on developing healthy nighttime sleep and daytime activity behaviors through a four-session, in-person program

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for sleep efficiency and insomnia severity using wrist actigraph and self-reported assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• education and coaching on developing healthy nighttime sleep and daytime activity behaviors

Trial Overview This study tests an intervention that includes education and coaching to promote healthy sleep-wake behaviors among older adults. It aims to establish effective daytime activities as part of a comprehensive approach to improve their overall sleep quality.

How Is the Trial Designed?

Group I: education and coaching on developing healthy nighttime sleep and daytime activity behaviors Experimental Treatment 1 Intervention

The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9476153/

Evaluating the impact of a sleep health education and ... At follow-up, the prevalence of poor sleep quality was significantly lower in the intervention condition (50%) (n=160 of 321) compared with the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10586750/

App-Supported Sleep Coaching: Implications for ... The results of these studies suggest that sleep coaching has a positive effect on subjective (and objective) sleep quality and daytime sleepiness in adult shift ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079225000620

Effects of sleep hygiene education for insomnia Sleep hygiene education (SHE) as a single therapy for insomnia still lacks sufficient evidence. This study aimed to quantify the effects of SHE on insomnia ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789421001337

A Pilot Randomized Controlled Trial of the Insomnia Coach ... Finally, for potential efficacy, at posttreatment, a larger proportion of Insomnia Coach (28%) than wait-list control participants (4%) achieved clinically ...

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)00683-9/fulltext

Clinical and cost-effectiveness of nurse-delivered sleep ... Results indicate superiority of nurse-delivered sleep restriction therapy over sleep hygiene in reducing insomnia symptoms at all timepoints. A ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10180237/

A scoping review of sleep education and training for nurses Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale were the outcome measures most frequently used. Although studies demonstrated improved sleep ...

7. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7734

Workplace Interventions to Promote Sleep Health and an Alert ... The intervention significantly improved self-reported sleep quality and reduced the number of participants who had poor sleep quality by 20% in ...

8. sleep.hms.harvard.edu sleep.hms.harvard.edu/education-training/public-education/sleep-and-health-education-program/sleep-health-education-86

Sleep and Health - Division of Sleep Medicine Risk Assessment​​ The study results below show that reducing sleep by just two or three hours per night can have dramatic health consequences. ...