Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
Insomnia is a widespread condition in which approximately one-third of adults in the United
States are symptomatic with 6% of the population meeting the diagnostic criteria for
insomnia. There is an increased risk of insomnia in certain segments of the population
including women, middle-aged and older adults, shift workers and individuals with medical or
psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to
those who report other serious illnesses such as major depression and congestive heart
failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric
disorders, medical and neurologic disorders. It can impair cognitive and physical
functioning.
Propofol is an approved drug administered intravenously for use in the induction and
maintenance of anesthesia or sedation. Some research suggests that propofol when administered
as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening
and the integrity of behavior following waking.
This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct
care of a Board Certified Anesthesiologist, dedicated to the study involving participants who
have refractory chronic primary insomnia and have not responded to conventional pharmacologic
therapies within the past 90 days. Each qualifying participant will receive an IV infusion of
the study medication for 5 consecutive nights. Assessments including polysomnography with
completion of questionnaires will occur at screening, Days 1 through 5 of study product
administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day
180.