NCT01790256

Comparison of Two Temperatures to Treat Insomnia

A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Cereve, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients. The current study is a two dose study to determine the optimal temperature for the Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and sleep efficiency.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DEVICE	Cereve Sleep System at 30 degrees C
DEVICE	Cereve Sleep System at 14-16 degrees C

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-02-13
• Last updated: 2015-05-22

Locations

9 sites across 1 country: United States