PMID- 29648642
OWN - NLM
STAT- MEDLINE
DCOM- 20190410
LR  - 20190410
IS  - 1550-9109 (Electronic)
IS  - 0161-8105 (Print)
IS  - 0161-8105 (Linking)
VI  - 41
IP  - 5
DP  - 2018 May 1
TI  - A novel forehead temperature-regulating device for insomnia: a randomized 
      clinical trial.
LID - 10.1093/sleep/zsy045 [doi]
LID - zsy045
AB  - STUDY OBJECTIVES: 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 degrees C, equivalent to 57-61 degrees F) for the treatment of 
      insomnia. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01966211.
FAU - Roth, Thomas
AU  - Roth T
AD  - Henry Ford Sleep Research Center, Henry Ford Hospital, Detroit, MI.
FAU - Mayleben, David
AU  - Mayleben D
AD  - CTI Clinical Research Center, Crestview Hills, KY.
FAU - Feldman, Neil
AU  - Feldman N
AD  - St. Petersburg Sleep Disorders Center, St. Petersburg, FL.
FAU - Lankford, Alan
AU  - Lankford A
AD  - Northside Hospital, Inc./SDCG, Atlanta, GA.
FAU - Grant, Timothy
AU  - Grant T
AD  - Miami Research Group, South Miami, FL.
FAU - Nofzinger, Eric
AU  - Nofzinger E
AD  - Ebb Therapeutics, Pittsburgh, PA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01966211
GR  - R43 HL097537/HL/NHLBI NIH HHS/United States
GR  - R44 HL097537/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Sleep
JT  - Sleep
JID - 7809084
RN  - 0 (Hypnotics and Sedatives)
SB  - IM
MH  - Adult
MH  - Body Temperature Regulation
MH  - Female
MH  - Forehead/*physiology
MH  - Heating/*methods
MH  - Humans
MH  - Hypnotics and Sedatives
MH  - Male
MH  - Middle Aged
MH  - Polysomnography
MH  - Prospective Studies
MH  - Sleep/*physiology
MH  - Sleep Initiation and Maintenance Disorders/*therapy
MH  - Sleep Latency
MH  - Temperature
MH  - Treatment Outcome
PMC - PMC5946849
EDAT- 2018/04/13 06:00
MHDA- 2019/04/11 06:00
PMCR- 2019/04/10
CRDT- 2018/04/13 06:00
PHST- 2017/04/20 00:00 [received]
PHST- 2018/04/13 06:00 [pubmed]
PHST- 2019/04/11 06:00 [medline]
PHST- 2018/04/13 06:00 [entrez]
PHST- 2019/04/10 00:00 [pmc-release]
AID - 4958122 [pii]
AID - zsy045 [pii]
AID - 10.1093/sleep/zsy045 [doi]
PST - ppublish
SO  - Sleep. 2018 May 1;41(5):zsy045. doi: 10.1093/sleep/zsy045.