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

112 Participants Needed

Trial Summary

What is the purpose of this trial?

Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia

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.

What data supports the effectiveness of the treatment Sleep education and relaxation for insomnia?

Research shows that sleep education programs, like those used in a televised course, can improve sleep by reducing the time it takes to fall asleep and increasing overall sleep duration. These programs also help people reduce their use of sleep medications, suggesting that education and relaxation techniques can be effective for managing insomnia. ^{1 2 3 4 5}

Is sleep education and relaxation safe for treating insomnia?

The research does not provide specific safety data for sleep education and relaxation treatments for insomnia, but it does highlight the importance of understanding safety behaviors in managing insomnia. ^{6 7 8 9 10}

How does the Sleep Education and Relaxation treatment for insomnia differ from other treatments?

The Sleep Education and Relaxation treatment is unique because it combines sleep education with relaxation techniques, focusing on reducing maladaptive thoughts and beliefs about sleep, which can improve subjective sleep perception. Unlike some treatments that rely on medication, this approach uses behavioral strategies to address insomnia. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

[Preparation and effect of a behavioral science-based education program for sleep improvement among medical students]. [2011]

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

Effect of sleep skills education on sleep quality in patients attending a psychiatry partial hospitalization program. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

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

"My Patient Can't Sleep": Resident-Led Curriculum Development for Insomnia Management. [2020]

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

Identifying safety behaviors in insomnia. [2019]

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

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. [2023]

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

A "Sleep 101" Program for College Students Improves Sleep Hygiene Knowledge and Reduces Maladaptive Beliefs about Sleep. [2022]

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

A Randomized Trial of a Self-Administered Parenting Intervention for Infant and Toddler Insomnia. [2020]

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

Update on the safety considerations in the management of insomnia with hypnotics: incorporating modified-release formulations into primary care. [2020]

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

Variations in sleep hygiene practices of women with and without insomnia. [2013]

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

Sleep restriction therapy and hypnotic withdrawal versus sleep hygiene education in hypnotic using patients with insomnia. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Usefulness of psychoeducational intervention in chronic insomnia: an actigraphic study. [2020]

14. Austria pubmed.ncbi.nlm.nih.gov

[Group therapy approaches in primary/psychophysiologic insomnias]. [2018]

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

Biofeedback and progressive relaxation treatment of sleep-onset insomnia: a controlled, all-night investigation. [2019]