Mind-Body Intervention for Sleep Deprivation

Overseen By Joan Duer-Hefele, RN, MA

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Northwell Health

Disqualifiers: Men, Age <40 or >60, Pregnancy, Cognitive impairment, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Mind-Body Intervention, including mindfulness, yoga, and guided walking, can help women in healthcare improve their sleep. Researchers aim to determine if these practices, delivered through online videos, can increase sleep duration and enhance sleep quality. The trial seeks women aged 40-60 with a history of sleeping less than 7 hours a night and experiencing high stress, who can use a smartphone and wear a Fitbit regularly. Participants will try different sequences of activities over 12 weeks to identify the most effective approach. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that activities like yoga and walking can improve sleep. Studies have found that yoga not only enhances sleep quality but is also safe for various groups, including women recovering from cancer. Walking is linked to better sleep and fewer sleep disturbances. Combining these activities with mindfulness, which involves being present and aware, can also enhance mental health. Although research continues, current findings suggest that these mind-body practices are generally safe and well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this mind-body intervention for sleep deprivation because it offers a personalized and holistic approach, unlike standard treatments like medication or cognitive behavioral therapy. This intervention combines mindfulness, yoga, and guided walking, providing a unique sequence of activities tailored to each participant's needs. Delivered through online videos, it offers a flexible and accessible method for improving sleep, potentially reducing dependency on pharmacological solutions. By integrating physical and mental exercises, this approach aims to create a more comprehensive and sustainable solution to sleep issues.

What evidence suggests that this trial's Mind-Body Intervention could be effective for sleep deprivation?

This trial will evaluate a Personalized Mind-Body Intervention (MBI) for sleep deprivation, consisting of mindfulness, yoga, and guided walking. Research has shown that activities connecting the mind and body, like those in this study, can improve sleep. Studies have found that mindfulness practices enhance sleep quality and elevate mood. Yoga is associated with better sleep and reduced stress. Walking is particularly beneficial, with some research suggesting it reduces sleep problems more effectively than yoga. Together, these activities aim to extend sleep duration and enhance overall well-being. Participants in this trial will experience these components in different sequences to assess their effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Karina Davidson, PhD, MASc

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for women aged 40-60 working in healthcare with a self-reported history of sleeping less than 7 hours per night for at least three months. They must be experiencing stress and able to use a smartphone and Fitbit regularly. Exclusions include severe illness, substance abuse, inability to walk or do yoga as advised by a doctor, pregnancy, men, those outside the age range, and non-Northwell employees.

Inclusion Criteria

After a two-week trial period, you consistently have short sleep and wear the Fitbit regularly.

You usually sleep less than 7 hours per night for at least 3 months.

I am a woman aged between 40 and 60.

Exclusion Criteria

I cannot wear a Fitbit regularly.

I have no surgeries planned within 6 months from joining the study.

You have not consistently slept very little or forgotten to wear the Fitbit and submit the surveys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Baseline

Participants complete a 2-week run-in period with no intervention to assess baseline sleep duration and adherence to Fitbit wear and survey submission

2 weeks

Virtual monitoring

Treatment

Participants receive a personalized Mind-Body Intervention (MBI) consisting of mindfulness, yoga, and guided walking in 2-week block sequences for a total of 12 weeks

12 weeks

Virtual sessions, 3 times per week

Follow-up

Participants are monitored for changes in sleep duration and quality, and physiological factors over a 2-week period post-intervention

2 weeks

Virtual monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Mind-Body Intervention (MBI)

Trial Overview The study tests if Mind-Body Interventions (MBI) like mindfulness, yoga, and guided walking can increase sleep duration over 12 weeks. Participants will first have their baseline sleep measured for two weeks using Fitbit; those adhering well are then randomly assigned one of two sequences of the MBI components.

How Is the Trial Designed?

Group I: Personalized Trial CBAABC Experimental Treatment 1 Intervention

Participants in Arm 2 will receive a Personalized Trial comprised of three components delivered in a CBAABC sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.

Group II: Personalized Trial ABCCBA Experimental Treatment 1 Intervention

Participants in Arm 1 will receive a Personalized Trial comprised of three components delivered in a ABCCBA sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

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/PMC9365743/

Effectiveness of a mindful nature walking intervention on sleep ... Findings suggest that both groups resulted in significant improvements in participants' trait mindfulness, sleep quality and mood after the intervention.

2. news-medical.net news-medical.net/news/20250715/Yoga-Tai-Chi-walking-and-jogging-found-to-improve-sleep-and-ease-insomnia.aspx

Yoga, Tai Chi, walking and jogging found to improve sleep ... Walking or jogging may result in a large reduction in insomnia severity of nearly 10 points, while Tai Chi may reduce poor sleep quality scores ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S108707921930005X

Walking is more effective than yoga at reducing sleep ... Overall, walking significantly improved sleep disturbance compared to yoga (p = 0.01). Statistically significant moderators included adherence rate for walking ...

4. ebm.bmj.com ebm.bmj.com/content/early/2025/07/09/bmjebm-2024-113512

Effects of various exercise interventions in insomnia patients Conclusion Exercise is an effective treatment for improving sleep in patients with insomnia. Among the various exercise interventions, yoga, Tai ...

5. kripalu.org kripalu.org/living-kripalu/yoga-and-sleep

Yoga and Sleep The results indicated that long-term yoga practice is associated with better sleep quality and lower levels of the stress hormone cortisol. In another study, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8191228/

Sleep, Cognition, and Yoga - PMC - PubMed Central Studies have revealed positive effects of yoga on sleep and cognitive skills among healthy adults as well as patients of some neurological diseases.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6801055/

Walk to a Better Night of Sleep: Testing the Relationship ... Collectively, results suggest that walking can improve sleep quality, depressive symptoms, and sleep efficiency, while decreasing nighttime wakefulness and next ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S175529662300073X

Effects of combining physical activity with mindfulness on ... Highlights · Combining physical activity and mindfulness shows promise for psychological health. · Evidence base is currently limited but rapidly developing.

9. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-020-02566-4

The effect of yoga on sleep quality and insomnia in women ... A trial in yoga for persistent fatigue breast cancer survivors showed yoga is safe and effective at improving fatigue severity, depressive moods ...