Sleep Education and Relaxation for Insomnia

(MBAT-2 Trial)

Overseen By Nalaka Gooneratne, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nalaka Gooneratne

Disqualifiers: Cognitive impairment, Sleep apnea, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help people with insomnia, a condition that makes it difficult to fall and stay asleep, leading to daytime tiredness and stress. Researchers are developing a non-drug treatment accessible via phone, focusing on education and relaxation techniques to improve sleep. The trial includes two groups, each trying a different version of this sleep education and relaxation plan. Individuals who take longer than 30 minutes to fall asleep at least three nights a week may be suitable for this study. As an unphased trial, it offers a unique opportunity to explore innovative, non-drug solutions for better sleep.

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 focuses on a non-drug treatment for insomnia, so it's best to check with the trial organizers for specific guidance.

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

Research has shown that good sleep habits can enhance sleep quality and mental sharpness in people with insomnia. Relaxation techniques have also improved sleep quality for many individuals. On average, those who learn about sleep hygiene increase their sleep time by about 11.5%. In some studies, nearly half of the participants experienced significant improvement.

The treatments under study—sleep education and relaxation—do not involve medication, making them safer than drugs. Because the trial focuses on behavior-based methods, serious safety issues are unlikely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for insomnia because they focus on behavioral education interventions, which are different from the usual reliance on medication. Standard treatments for insomnia often involve pharmaceuticals like benzodiazepines or non-benzodiazepine sleep aids, which can have side effects and dependency risks. The sleep education and relaxation techniques in this trial offer a non-pharmacological approach, emphasizing sustainable lifestyle changes and relaxation methods that could improve sleep naturally. This approach could lead to long-term relief without the side effects associated with traditional medication.

What evidence suggests that this trial's treatments could be effective for insomnia?

Research has shown that learning about sleep and using relaxation techniques can help treat insomnia. This trial will compare two approaches: "Sleep education and relaxation 1" and "Sleep education and relaxation 2." One study found that these methods improved sleep quality and daytime functioning, with success rates of about 64% after 8 weeks, 71% after 16 weeks, and 72% after 24 weeks. Another study demonstrated that learning about sleep reduced sleep problems, as evidenced by better scores on sleep quality tests. While some studies suggest that learning about sleep habits alone requires more evidence, combining it with other methods has yielded positive results in improving insomnia symptoms. These techniques aim to enhance sleep habits and reduce stress, offering a way to address sleep issues without medication. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults with insomnia, experiencing trouble falling asleep at least three nights a week. Participants must be able to communicate verbally and in written English, have no cognitive impairments or diagnosed non-insomnia sleep disorders like sleep apnea, and must not have upper extremity motor impairments.

Inclusion Criteria

It takes me over 30 minutes to fall asleep at least 3 nights a week.

Exclusion Criteria

Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages)

I do not have any cognitive impairments that would prevent me from following study instructions.

I do not have severe arm or hand paralysis that would stop me from participating in MBAT therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral education intervention about sleep and relaxation

4 weeks

Follow-up

Participants are monitored for changes in sleep onset latency and other outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep education and relaxation 1
• Sleep education and relaxation 2

Trial Overview The study tests two types of monitored breathing awareness therapy (MBAT) delivered via mobile devices as a non-drug treatment for insomnia. It aims to see if these therapies can reduce the time it takes to fall asleep and improve overall sleep quality in older adults.

How Is the Trial Designed?

Group I: Sleep education and relaxation 2 Experimental Treatment 1 Intervention

Behavioral education intervention about sleep and relaxation

Group II: Sleep education and relaxation 1 Active Control 1 Intervention

Behavioral education intervention about sleep and relaxation

Who Is Running the Clinical Trial?

Nalaka Gooneratne

Lead Sponsor

Trials

2

Recruited

140+

Advanced Medical Electronics

Collaborator

Trials

6

Recruited

430+

Published Research Related to This Trial

Patients who received education on using sleep-enhancing tools (like eye masks and white noise machines) experienced a significant reduction in fatigue compared to those who only received general sleep information, indicating that targeted education can improve patient outcomes.

While the education intervention showed benefits in fatigue, it did not significantly affect other sleep-related issues or the length of hospital stay, suggesting that while helpful, the approach may need to be part of a broader strategy for improving overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial. Farrehi, PM., Clore, KR., Scott, JR., et al.[2019]

Melatonin receptor agonists have the lowest rate of adverse events (43.1 per 1000), while non-benzodiazepine benzodiazepine receptor agonists have the highest (255.0 per 1000), indicating a significant difference in safety profiles among insomnia medications.

Benzodiazepines showed the highest efficacy in improving sleep outcomes with an effect size of 1.94, while melatonin receptor agonists had the lowest efficacy (0.109), suggesting that histamine antagonists may offer the best risk-benefit ratio for treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. Cheung, JMY., Scott, H., Muench, A., et al.[2023]

A psychoeducational program called 'Sleep 101' significantly improved sleep hygiene knowledge and reduced negative beliefs about sleep among college students, as shown by a study involving sleep log recordings and workshops.

Participants in the Sleep 101 program experienced shorter sleep onset times compared to those in the control group, suggesting that such brief educational interventions can effectively promote healthier sleep practices in young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "Sleep 101" Program for College Students Improves Sleep Hygiene Knowledge and Reduces Maladaptive Beliefs about Sleep. Kloss, JD., Nash, CO., Walsh, CM., et al.[2022]

In a study involving 239 families, a self-administered DVD intervention called the Sleep Easy Solution significantly improved perceptions of children's sleep problems compared to a wait-list group, indicating its efficacy in addressing pediatric sleep issues.

The DVD intervention also led to longer continuous sleep periods and increased parental confidence in managing their child's sleep, suggesting it is a valuable tool for families facing sleep challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of a Self-Administered Parenting Intervention for Infant and Toddler Insomnia. Stevens, J., Splaingard, D., Webster-Cheng, S., et al.[2020]

A simple education program that included a 90-minute lecture and a 2-week practice session significantly improved sleep knowledge and habits among 6th-year medical students, with notable enhancements in sleep quality and attitudes towards sleep management.

Students who participated in both the lecture and practice learning session showed greater improvements in sleep-related issues, such as nightmares and daytime sleepiness, compared to those who only attended the lecture, highlighting the effectiveness of hands-on practice in medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preparation and effect of a behavioral science-based education program for sleep improvement among medical students]. Ueda, M., Adachi, Y., Hayama, J., et al.[2011]

A psycho-educational training course for sleep disorders, viewed by about 200,000 people, led to a significant decrease in sleep latency by 25 minutes and an increase in total sleep duration by nearly 40 minutes among participants.

Approximately 40% of participants who were using hypnotic drugs stopped their use after completing the course, indicating that this approach is not only effective but also cost-effective by reducing reliance on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of insomnia through mass media, the results of a televised behavioral training programme. Oosterhuis, A., Klip, EC.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11407310/

Analysis of the Improvement Sequence in Insomnia ... The treatment effectiveness rate at 8, 16, and 24 weeks was 64.46%, 71.50%, and 72.43%, respectively. The sleep quality and daytime functioning, ...

2. 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 ...

3. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-024-02057-1

Effectiveness of a multi-component sleep-mood group ... Our results showed remission rates of approximately 50% (reaching below 10 on the ISI), while treatment response (reduction of 8 points) was ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/07420528.2024.2337007

Full article: The impact of sleep education, light intervention ... PSQI scores were statistically reduced indicating better sleep. Scores after the intervention significantly decreased in ESS and ISS. Sleep ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11610801/

Sleep hygiene efficacy on quality of sleep and mental ... The results of the study provide compelling evidence that good sleep hygiene can help enhance insomniacs' mental ability and sleep quality.

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

Sleep Health Promotion Interventions and Their Effectiveness One review showed that varying relaxation techniques improved sleep quality with a medium effect size [44]. One review demonstrated that ...

8. mdpi.com mdpi.com/2624-5175/7/3/40

Who Benefits the Most from Sleep Hygiene Education? ... On average, sleep duration increased by 11.5% (SD = 20.3%), and 48% of participants (49 out of 102) exhibited a ≥10% increase. These findings suggest that the ...

9. sleep.hms.harvard.edu sleep.hms.harvard.edu/education-training/public-education/sleep-and-health-education-program/sleep-health-education-45

Why Sleep Matters: Consequences of Sleep Deficiency A lack of adequate sleep can affect judgment, mood, ability to learn and retain information, and may increase the risk of serious accidents and injury.