Science-based Approach to the
Management of Sleeplessness
Guided by Dr Eric Nofzinger, a pioneer in sleep neuroimaging and practicing sleep clinician for over 30 years, Ebb uses a holistic approach in the management of sleeplessness. The Ebb solution addresses the physiological, behavioral and temporal components of sleeplessness by using targeted cooling to the forehead along with the skilled intervention of a trained sleep coach.
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The goal of all Ebb interventions is to move an individual towards their ideal restorative sleep and away from forces that keep them from achieving this sleep. Objective indicators of ideal sleep may include short sleep latencies, few to no awakenings across the night, and high levels of slow waves in the EEG that are prominent over the frontal cortex. At the brain metabolic level, there is a dramatic-reduction in cerebral metabolism, especially in the frontal cortex.
Hyperarousal is a term to describe a physiologic and behavioral state of individuals with sleeplessness. These individuals are shown to have long sleep latencies, multiple awakenings across the night, and intrusion of faster frequencies into the EEG rhythms indicative of brain arousal. At the brain metabolic level, this hyperaroused sleep can be associated with increased cerebral metabolism especially across the frontal cortex.
Ebb Targets Hyperarousal
Ebb uses PrecisionCool™ Technology which is based on the principles of cerebral hypothermia to move an individual away from a hyperaroused state back to one that naturally allows their ideal sleep to occur. The Ebb headband continuously cools the forehead to the optimal temperature range. Brain imaging studies have shown that the Ebb device reduces cerebral metabolism allowing a person to reach deeper, more restorative sleep faster.
Ebb’s Sleep Coaching Program
The ideal management of sleeplessness also involves behavioral manipulations empirically shown to move sleep toward deeper, more restorative sleep processes under the guidance of a trained coach. The Ebb Sleep Coach program is a once-weekly, 4-week telephone and digitally based program led by National Board-Certified Health and Wellness Coaches who are trained in the core principles of cognitive behavior therapy for insomnia. Ebb coaches provide guidance on healthy sleep behaviors utilizing core behavior change principles based on extensive scientific literature on the behavioral management of sleeplessness and in motivational change.
A novel forehead temperature-regulating device for insomnia: a randomized clinical trial.
Roth T, Mayleben D, Feldman N, Lankford A, Grant T, Nofzinger E. SLEEP. 2018;41(5).
Insomnia is one of the most common disorders in the general population. Hypnotic medications are efficacious, but their use is limited by adverse events (AEs). This study evaluated the safety and efficacy of a novel forehead temperature-regulating device that delivers frontal cerebral thermal therapy (maintained at 14-16°C, equivalent to 57-61°F) for the treatment of insomnia.
This was a prospective, randomized controlled trial involving two nights of therapy in 106 adults diagnosed with insomnia. The main outcome measures included latency to persistent sleep and sleep efficiency derived from polysomnographic (PSG) recordings and frequency and severity of AEs.
Frontal cerebral thermal therapy produced improvements over sham on convergent measures of sleep latency. The safety profile was comparable to sham treatment. Statistically significant differences were not found in the two a priori co-primary endpoint measures absolute latency to persistent sleep (p = 0.092) or absolute sleep efficiency. Frontal cerebral thermal therapy produced improvements over sham in other convergent measures of sleep latency including relative changes from baseline in latency to persistent sleep (p = 0.013), the latency to stage 1 NREM sleep (p = 0.006), the latency to stage 2 NREM sleep (p = 0.002), a trend for the latency to stage 3 NREM sleep (p = 0.055), and an increase in the minutes of sleep during the first hour of the night (p = 0.024).
Two-night frontal cerebral thermal therapy produced improvements in PSG measures of insomnia patients’ ability to fall asleep and had a benign safety profile. Further studies are warranted to determine the role of this therapy in the longer-term management of insomnia.
Durability of effects of forehead cooling on EEG sleep measures in insomnia patients from 2- to 30-nights use and 6-month safety results.
Rippole D, Schirm J, Nofzinger E. SLEEP 2020.
Forehead cooling has previously been shown to improve EEG sleep measures in insomnia patients when applied for 2 nights. The current study assessed the durability of these effects after 30 days in home use as well as safety over 6 months in home use.
This was a prospective, open label trial involving 32 adults meeting diagnostic criteria for primary insomnia who previously had participated in a 2 night in lab EEG sleep study. In the current study, participants received an additional 30 nights in home treatment, then had repeat EEG sleep studies performed to determine if effects noted at 2 nights remained durable after 30 days. Subjects also participated in an open label 6-month in-home use safety study.
Baseline, 2-night and 30-night EEG sleep measures for sleep latency were 80.7 + 73.8, 25.3 + 22.6, 26.2 + 25.8 minutes (2- to 30-night difference p=0.81, NS) and for sleep efficiency were 67.4 + 15.7, 81.4 + 11.2, 83.2 + 13.6 (2- to 30-night difference p=0.18, NS). Subjective sleep quality (0-100 scale with 100=best) at baseline, 2-night and 30-nights were 29.8 + 15.2, 48.3 + 20.2, 57.2 + 21.1 (linear improvements significant over time p<0.001). No adverse effects were seen across 6-months use.
Forehead cooling demonstrated durability of effects on EEG sleep measures from 2- to 30-nights use. Continuing improvements in subjective sleep quality when measured over time from baseline assessments to the end of the 30-night in-home use period were noted. Forehead cooling was safe over 6 months use in the home as evidenced by no serious device related adverse events.
Efficacy of a Forehead-cooling Device for Treating Insomnia in Veterans.
Nofzinger E. SLEEP 2020.
In 2 independent studies, we explored whether a forehead-cooling device was effective in improving insomnia in veterans.
Both studies were uncontrolled and exploratory in nature. The first study involved 20 veterans who expressed interest in using the forehead-cooling device and received 4 weeks treatment. The second study involved 19 veterans who were recruited via media to participate in a 4-week study and were compensated for their participation. All participants completed questionnaires before and after treatment.
In the retrospective analysis, veterans had improvements over baseline in insomnia severity index (M + SD =17.6 + 4.7 pre- vs 6.9 + 3.5 post-treatment, t(19) = -9.4, p <0.00001), in sleep latency (M + SD = 61.7 + 49.1 minutes pre- vs 25.0 + 20.8 minutes post-treatment, t(19) = -4.6, p <0.001) and in minutes awake after sleep onset (M + SD =78.7 + 57.8 minutes pre- vs 29.9 + 18.3 minutes post-treatment, t(19) = -4.0, p <0.001). In the prospective study, veterans had improvements in insomnia severity index over baseline (M + SD = 20.7 +3.8 pre- vs 9.5 + 7.5 post-treatment, t(18) = 5.8, p <0.00001), depression severity on the PHQ-9 (M + SD = 21.5 + 6.1 pre- vs 14.2 + 5.1 post-treatment, t(18) =4.1, p<0.001) and anxiety severity on the GAD 7 (M + SD = 9.8 + 7.1 pre- vs. 6.2 + 5.4 post-treatment, t(18) = -3.1, p<0.01).
Use of a forehead-cooling device improved insomnia in veterans. These findings were replicated in an independent prospective trial. Reductions in depressive and anxiety symptoms from baseline were also noted in the prospective study. These promising preliminary data suggest the need for further large scale randomized controlled trials to establish the efficacy of forehead-cooling on insomnia in veterans.
A preliminary study on the efficacy of a forehead-cooling device for relieving menopausal sleep difficulties and hot flashes.
Baker, F., Zambotti, M., Chiappetta, L., Nofzinger, E. SLEEP 2020
Many women experience sleep difficulties in the approach to menopause and post-menopause, with about 25% experiencing severe symptoms that impact daytime functioning and quality of life. Hot flashes contribute to these sleep difficulties, being associated with nocturnal awakenings, poorer sleep quality, and chronic insomnia. New non-pharmacological sleep solutions have become available, including a forehead cooling device that was developed to target hyperactivity of the frontal cortex in insomnia sufferers. Here, we explored whether this device was effective in improving subjective sleep and hot flashes in menopausal-age women.
This study was an open-label, in-home investigation of the efficacy of nightly treatment with a forehead cooling device in 20 women (55.1 ± 4.2 years) with insomnia symptoms and daily hot flashes. Participants completed daily diaries assessing sleep quality and hot flashes across a baseline week (no treatment) followed by 4 weeks of treatment. They also completed questionnaires before and after treatment including the insomnia severity index and the hot flash related daily interference scale.
Women reported better sleep quality with a shorter sleep onset latency and fewer awakenings during the first week of device use, with further improvements over time, relative to baseline (p <0.001). Women also reported fewer nocturnal hot flashes that were less severe during treatment (p<0.001). They also had lower insomnia severity scores post-treatment (9.3±5.8) compared to pre-treatment (20.0±5.7) (p<0.001), with 17 participants showing a reduction of 6 points or greater on the insomnia severity index. There was also a significant reduction in hot flash related daily interference post-treatment (p<0.001).
Use of a forehead cooling device during the night improved subjective sleep quality and reduced insomnia symptoms and hot flash frequency and severity in this preliminary study of menopausal-age women. Further large scale randomized controlled trials are required to determine efficacy.
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Frequently Asked Questions
Will the patient see results the first time they use Ebb?
In clinical trials, most study subjects experienced benefits within the first 2 nights of using Ebb. After using Ebb for 30 days, people with sleeplessness reported improved sleep quality as well as better mood and alertness the next morning.
Should patients use Ebb every night?
Ebb is non-habit forming and safe to use every night. Wearing Ebb each night along with healthy sleep habits, will help the body adjust to a new healthy sleep/wake rhythm. As with any therapy, frequency of use should be individualized according to their response.
What temperature setting should patients start with?
For initial use, we suggest starting with a temperature setting of P7 and then adjusting for comfort. It could take up 10 minutes for the headband to reach the chosen temperature setting. All of the temperature settings are within the therapeutic range of 57-61°F (14-16°C) which demonstrated efficacy in the clinical trials.
Are there any contraindications?
Use of Ebb presented few adverse events in clinical trials; there are no formal contraindications for use. Patients with cold sensitivity reactions such as Raynaud’s Disease should not use cooling therapies. Please refer to the Instructions for Use for more information.
- Nofzinger EA, Buysse DJ, Miewald JM, et al. Human regional cerebral glucose metabolism during non-rapid eye movement sleep in relation to waking. Brain. 2002;125(Pt 5):1105-1115.
- Buysse DJ, Germain A, Hall M, Monk TH, Nofzinger EA. A Neurobiological Model of Insomnia. Drug Discov Today Dis Models. 2011;8(4):129-137.
- Nofzinger EA, Buysse DJ, Germain A, Price JC, Miewald JM, Kupfer DJ. Functional neuroimaging evidence for hyperarousal in insomnia. Am J Psychiatry. 2004;161(11):2126-2128.
- Nofzinger EA, Nissen C, Germain A, et al. Regional cerebral metabolic correlates of WASO during NREM sleep in insomnia. J Clin Sleep Med. 2006;2(3):316-322.
- Nofzinger E, Miewald J, Price J, Buysse D. Frontal Cerebral Hypothermia: A New Approach to the Treatment of Insomnia. Abstract presented at SLEEP; 2009.
- Roth T, Mayleben D, Feldman N, Lankford A, Grant T, Nofzinger E. A novel forehead temperature-regulating device for insomnia: a randomized clinical trial. Sleep. 2018;41(5).