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Clinical Studies

Renowned researcher, Dr. Eric Nofzinger, spent decades studying peoples’ sleeping brains and the positive impact that continuous cooling would have. These years of research have resulted in the Ebb CoolDrift product, the first and only drug-free solution clinically validated to target your racing mind to induce sleep.

Key Trials:

1. Ebb® with PrecisionCool™ technology was demonstrated in clinical studies to help people with sleeplessness to fall asleep and enter deeper, more restorative sleep faster

(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):zsy045. doi:10.1093/sleep/zsy045)

Three independent clinical studies were conducted in seven prestigious sleep centers across the U.S. on more than 230 patients. Over 3,800 research nights, Ebb demonstrated the safety and effectiveness of its precise cooling. In the primary randomized controlled trial, participants used Ebb for multiple nights in a sleep lab and were assessed by Polysomnographic recordings analyzed by sleep clinicians. The product’s precise cooling produced improvements in the ability for participants to fall asleep and enter deeper, more restorative sleep faster. Participants experienced no significant side effects.

2. Ebb CoolDrift Versa improves sleep in individuals with sleeplessness. (SLEEP 2020; Abstract 1198)

This study aimed to determine if Ebb CoolDrift Versa would have similar effects as the Ebb CoolDrift Luxe in individuals with sleeplessness. Individuals with sleeplessness (N=30) were recruited and studied at 2 geographic locations. Each participant received pre- and post- treatment insomnia severity as well as daily sleep diary assessments over 1 week of baseline and 4 weeks of treatment. Participants’ sleeplessness symptoms improved over baseline in insomnia severity index (p<0.00001), sleep latency (p<0.00001), in minutes awake after sleep onset (p<0.00001) and in sleep quality (p<0.00001). Effects of Ebb CoolDrift Versa were comparable to those seen with Ebb CoolDrift Luxe.

3. Ebb CoolDrift improves insomnia in veterans with multiple medical and psychiatric co-morbidities.

(Mysliwiec V, Neylan TC, Chiappetta L, Nofzinger EA. Effects of a forehead cooling device in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions: a pilot study [published online ahead of print, 2020 Jun 22]. Sleep Breath. 2020;10.1007/s11325-020-02126-w. doi:10.1007/s11325-020-02126-w)

Two studies showed beneficial effects of Ebb CoolDrift on insomnia. The first study involved 20 veterans and the second study involved 19 veterans. In the first study, veterans had improvements over baseline in insomnia severity index (p <0.00001), sleep latency (p <0.001) and in minutes awake after sleep onset (p <0.001). In the second study, veterans had improvements in insomnia severity index over baseline (p <0.00001), depression severity ( p<0.001) and anxiety severity (p<0.01).

4. Ebb CoolDrift Luxe improves sleeplessness and hot flash severity in menopausal women. (SLEEP 2020; Abstract 0482)

An open-label, in-home investigation of the efficacy of nightly treatment with Ebb CoolDrift Luxe in 20 women (55.1 ± 4.2 years) with insomnia symptoms and daily hot flashes demonstrated 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 compared to pre-treatment (p<0.001). There was also a significant reduction in hot flash related daily interference post-treatment (p<0.001).

5. Ebb CoolDrift improves sleep long term and is safe to use in individuals with insomnia. (SLEEP 2020; Abstract 0515)

The durability of the effects of Ebb CoolDrift were assessed after 30 days in home use as well as safety over 6 months in home use in 32 adults meeting diagnostic criteria for insomnia. Participants received 2 nights and 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. The effects noted for 2 nights use remained stable after 30 days in home use. No side effects were seen across 6-months use.

Key Research:

1. Restorative sleep is associated with reductions in frontal cortex metabolism (Brain 2002, 125, 1105-1115)

Dr. Nofzinger’s functional neuroimaging study in healthy sleepers demonstrated that deep, restorative sleep is associated with reductions in metabolism in the frontal cortex, our thinking brain, that lies directly behind the forehead.

2. Evidence of racing thoughts and increased frontal cortex metabolism during sleep in adults with sleeplessness

(Journal of Clinical Sleep Medicine 2006;2: 316-322)

Dr. Nofzinger’s clinical study published in 2006 demonstrated that, in contrast to healthy sleepers, the frontal cortex works overtime during sleep in individuals with sleeplessness, creating racing thoughts and making it difficult for the brain to drift naturally into sleep and stay asleep across the night. This racing mind effect is demonstrated via increased metabolic activity in the frontal cortex of the brain during sleep.

3. Precise, constant therapeutic cooling of the forehead reduces racing thoughts in adults with sleeplessness (SLEEP 2009; Abstract 0881)

Dr. Nofzinger’s clinical study demonstrated that applying precise, constant cooling to the forehead of individuals with sleeplessness led to significant reductions in metabolic activity in the frontal cortex of the brain. These reductions in activity allowed participants to fall asleep faster and achieve better sleep across the night.

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