NCT00415714

Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

A Randomized Controlled Pilot Trial Testing the Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (planned)
• Sponsor: Helicor · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the efficacy of a portable biofeedback device on improving sleep latency and other sleep variables such as nocturnal awake time and daytime functioning in persons with primary insomnia.

Detailed description

There is evidence that when compared to normal controls, persons with insomnia exhibit increased cognitive and physiological arousal and higher overall metabolic rate during sleep, particularly at sleep onset. There is evidence that reducing this arousal may impact sleep latency and nocturnal awake time. Although relaxation treatments have been integrated into behavioral therapies, there are numerous barriers to their implementation in real world settings. The present study is designed to examine the effect of a portable biofeedback device designed to induce physiological relaxation as compared to an inactive sham control device condition in reducing sleep onset latency in persons with primary insomnia over a 4 week period at three separate research sites.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DEVICE	Portable Biofeedback

Timeline

• Start date: 2006-09-01
• Completion: 2007-10-01
• First posted: 2006-12-25
• Last updated: 2007-01-29

Locations

1 site across 1 country: United States