Sleep Homeostasis in Primary Insomnia

Completed · Not applicable

Conditions studied: Primary Insomnia

In brief

About 10% of the population is believed to suffer from Primary Insomnia. It is also believed that people with chronic insomnia have a sleep system that is essentially out of alignment (we call this "homeostatic dysregulation"). We also know that a certain form of non-medication therapy called cognitive-behavioral therapy is a very effective treatment for insomnia. It is not known, however, whether cognitive-behavioral therapy actually works by bringing the brain's sleep system back into alignment ("sleep homeostasis"). One of the methods used to measure sleep homeostasis is to observe a person's brain waves during sleep and particularly during sleep that follows a period of sleep loss. The purposes of this study are to first learn whether persons with insomnia do have a misaligned sleep system compared to persons who do not have insomnia by assessing the sleep of people before and after a period of extended sleep loss. Second, the study will determine whether cognitive-behavioral therapy can re-regulate the sleep system and its response to sleep loss. Third, the final purpose is to examine whether the immune system of people with insomnia is more altered following sleep loss than in the comparison group and whether cognitive-behavioral therapy can alter immune function.

Key facts

Study ID

NCT00256503

Run by

University of Rochester

People needed

18

Starts

2005-12-01

Expected to finish

2008-12-01

Last updated by the study team

2016-01-12

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Primary Insomnia (PI) subjects:
• Difficulty falling or staying asleep for 6 or more months as evidenced by (a) 30 or more minutes to fall asleep on 3 or more nights per week, or (b) early morning awakenings > 30 minutes prior to desired rise time on 3 or more nights per week
• Reported impaired daytime function attributed to insomnia
• Good-Sleeper (GS) controls:
• No history of sleep disorders
• No current sleep complaints and/or complaints of daytime fatigue or sleepiness
• Sleep characterized as restorative and relatively "unperturbable"; and will be defined as: 5-15 minutes to fall asleep and no more than two awakenings per night of > 5 minutes duration

You may not qualify if…

• Significant medical or psychiatric illness
• Diagnosed or occult sleep disorders (evident on screening PSG) other than PI
• Hearing or memory impairments
• Non-fluency in spoken or written English
• History of head injury (w/ loss of consciousness) or seizures
• Prescription medication or recreational drug use within 4 weeks of laboratory study
• Tobacco use or consume more than 3 cups of coffee per day (or an equivalent dose of caffeine)

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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