Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Thermal Therapy Device for Insomnia Effective

Sleep; ePub 2018 Apr 10; Roth, Mayleben, et al

2-night frontal cerebral thermal therapy produced improvements in polysomnographic (PSG) measures of insomnia patients’ ability to fall asleep and had a benign safety profile, according to a recent study. Researchers conducted a prospective, randomized controlled trial involving 2 nights of therapy in 106 adults diagnosed with insomnia. The main outcome measures included latency to persistent sleep and sleep efficiency derived from PSG recordings and frequency and severity of adverse events.

They found:

  • The safety profile was comparable to sham treatment.
  • Statistically significant differences were not found in the 2 a priori co-primary endpoint measures absolute latency to persistent sleep 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, the latency to stage 1 non-rapid eye movement (NREM) sleep, the latency to stage 2 NREM sleep, a trend for the latency to stage 3 NREM sleep, and an increase in the minutes of sleep during the first hour of the night.


Roth T, Mayleben D, Feldman N, Lankford A, Grant T, Nofzinger E. A novel forehead temperature-regulating device for insomnia: A randomized clinical trial. [Published online ahead of print April 10, 2018]. Sleep. doi:10.1093/sleep/zsy045.

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