In August 2021, we conducted a pilot study to see if we could improve upon the most effective sleep therapy in the world, Cognitive Behavioral Therapy for Insomnia (CBT-I), in order to help a group that desperately needs it, veterans. The program, SIXTY TWO ROMEO, involves the philosophy of CBT-I and a circadian scheduling device called the Rest Node (www.restnode.org). Across all participants, who were all U.S. Military combat veterans, sleep latency reduced by 38.4%, deep sleep increased by 29.2% and REM sleep increased by 36.7%. Here’s how we did it.
Philosophy of CBT-I
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the most effective treatment for insomnia in existence. According to Dr. Jacobs of Harvard University, CBT-I improves sleep in 75-80% of insomnia patients and reduces or eliminates sleeping pill use in 90% of patients. One study published by the National Institute of Health described what we already knew, that when compared to benzodiazepines, non-benzodiazepine receptor agonists, antidepressants, and antihistamines, CBT-I out significantly out-performed drugs in the long-term and was only mildly less effective in the short-term (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3481424/). The short-term statistic is simply because a CBT-I program takes 6-8 weeks and the effects begin to take place after habits form in week three and four. Otherwise, CBT-I is superior in every way, to include no direct side effects. Below are the four ways we improved upon the most effective sleep therapy in the world:
1. Reduce Barriers To Entry for patients seeking CBT-I
1. Reduce the barriers to entry for patients seeking CBT-I.
By replacing clinicians with sleep coaches and therapy with education, we can increase the number of people helping others with sleep while making it easier for people to receive the help they need. Because there are no direct side effects to CBT-I, it is safe in almost every situation. Holding an M.D., PhD. or LMFT are great prerequisites, however these degrees and licenses significantly limit the footprint of available CBT-I care for sleep patients. The philosophies behind CBT-I are easy to learn and can be understood by almost anyone. That’s why the Veteran Affairs (VA) Administration and private companies have released CBT-I apps for broad consumption (https://mobile.va.gov/app/cbt-i-coach).
2. Increase Availability By Going Virtual.
Since 2020, we were all forced to go virtual to avoid spreading the COVID-19 virus. This created many challenges but ultimately taught us the value of digital communication in a work-from-home environment. This also allowed for companies to fan out the geographic location of their employees. For us, using a virtual format allowed us to work with participants across the country from the comfort of their home. This saves time and money on traveling to meet a clinician to receive CBT-I. This also makes it easy to hold larger classes.
3. Maximize Our Impact By Holding Group Classes
With millions of people needing immediate assistance with sleep and limited numbers of sleep professionals available, the need to hold group classes has never been more important. Mathematically, the only way to address the millions of people affected by the sleep epidemic is to increase the number of sleep professionals and the footprint they can address. By using sleep coaches with 160 hours of training and holding class sizes of 15, we can rapidly and exponentially begin to address the sleep epidemic. With that said, we acknowledge the importance of individualized care. Limiting the classes to no more than 30 participants ensures that one-on-one attention can be achieved, just as we do in university settings.
4. Increase Compliance With A Circadian Scheduling Device
The biggest challenge with current CBT-I practitioners is compliance. Compliance means adhering to the protocol given to the patient. With SIXTY TWO ROMEO, participants receive a light/sound device that uses circadian scheduling software. This device automates the sleep routine by turning on various lights and sounds in the bedroom at specific times each night. This type of signaling acts as a reminder in the bedroom, where traditional CBT-I clinicians do not have access. This increases compliance by offering reminders every night and morning so the participant can stick to their predetermined circadian schedule. Over the course of our program, participants can begin to develop a positive association to the light and sound triggers. This further aides in the development of a consistent bedtime routine.
Sleep latency is how long it takes to fall asleep. The ballistocardiogram measures sleep latency by timing the first readings on the mat to the time when sleep staging is detected. Sleep organizations agree that sleep latency should be less than 1200 seconds [20 minutes]. While some participants reported sleep latency greater than one hour prior to the study, the week one baseline showed an average of 1,579 [26.3 minutes]. The chart shows a steady decline in sleep latency throughout the study for all participants. Sleep latency in participants reduced from an average 1579 seconds [26.3 minutes] to 972 seconds [16.2 minutes]; an improvement of 38.4%. Participants therefore successfully reduced their average sleep latency during the program to a healthy range. Sleep journals indicated improved sleep latency and reduced distress from sleep latency.
Deep sleep is when the body completely relaxed while muscle repair, brain rinsing and memory formation occur. The ballistocardiogram detects deep sleep by measuring [reduced] gross movements in combination with [slow] heart rate and [relaxed] heart rate variability. The total estimated time in this state is recorded as total deep sleep. Sleep organizations report that adults should sleep 7-9 hours and 13-23% of that should be in deep sleep. A healthy range for total deep sleep is therefore 3300 seconds [55 minutes] to 7440 [124 minutes]. The chart shows a marked increase in total deep sleep over the six-week program. On average, total deep sleep measurements increased from 4,531 seconds [75.5 minutes] to 5,856 [97.6 minutes]; an improvement of 29.2%. Participants successfully increased their total deep sleep during the program well into a healthy range. Sleep diaries indicated participants felt more refreshed and rested during the study.
REM sleep, also known as Rapid Eye Movement sleep, is the stage of sleep where dreams, memory consolidation and psychological repair occur. The ballistocardiogram measures REM sleep when there is no gross movement detected while heart rate increases. Total REM sleep is estimated by totalling each of these periods throughout all sleep cycles. Sleep organizations report that sleepers should get at least 75 minutes of REM sleep each night. A healthy range for REM sleep is therefore approximately 5000 seconds [84 minutes] to 8000 seconds [135 minutes]. The chart shows a significant increase in total REM sleep over the course of the study. On average, total REM sleep increased from 4488 seconds [74.8 minutes] to 6,139 seconds [102.3 minutes]; a 36.7% improvement. Adults should sleep 7-9 hours per night and spend 20-25% of that time in REM sleep. Participants successfully increased their average total REM sleep during the program from deprived to healthy. Sleep diaries indicated that in the latter part of the study, participants reported feeling happier and more positive following sleep.
In conclusion, we have shown that the SIXTY TWO ROMEO program, which uses the philosophy of CBT-I and increases compliances with a circadian scheduler in the bedroom has the ability to reshape sleep in some of the most challenging sleepers: combat veterans. There were several limitations to the pilot study to include: small number of participants, lack of prior IRB approval, and no control group. Because of the success of this pilot study, in the future, we will conduct another study that addresses all of those limitations. In the short term, we will continue to help people with sleep issues with a special focus on veterans and first-responders.
As of 2022, the SIXTY TWO ROMEO program was licensed to the Creed of Peaceful Warriors, a non-profit offering the program to veterans and first-responders free of charge. To sign up for the program, simply visit the website, join the organization and fill out the application (www.62romeo.org/participants). In order to keep this amazing program running, you can donate directly to the non-profit by joining the organization and completing a digital donation (www.62romeo.org/sponsors). All donations are tax deductible and are used directly to heal veterans and first-responders through the program.
The SIXTY TWO ROMEO program is not intended to diagnose, treat or cure any disease nor is a medical intervention. It uses publicly available information on sleep hygiene and the philosophical teachings of CBT-I to provide tools to participants in an educational format. No prescriptions, therapies, or medical procedures were offered. All participants consulted with their doctors before starting the program to ensure there were no significant risk factors to participating. Existential Technologies Inc. paid for the study and is a direct beneficiary of future sales of the Rest Node (www.restnode.org) and therefore holds an inherent bias. Every attempt was made to remove this bias while searching for positive outcomes to the sleep epidemic. Dr. Mishra, M.D. reviewed five clinical questionnaires for participants before and after the program. Dr. Citaku M.D. maintained sole access to the individually protected health information (PHI) contained within sleep data measurements and remained external from any influence on the study.