Sleep Homeostasis in Primary Insomnia

NCT00256503 | Completed

• 2 other identifiers: 33-CA-05012331
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Insomnia

Keywords

Primary Insomnia; Insomnia; Sleep

Outcome Measures

Primary Outcomes (1)

• Slow Wave Sleep (SWS)

  Mean minutes of slow wave sleep as measured by standard sleep stage scoring

  Baseline to end of Study (up to 12 weeks)

Secondary Outcomes (1)

• Delta Power

  Baseline to end of study (up to 12 weeks)

Study Arms (2)

Insomnia

EXPERIMENTAL

Insomnia subjects who receive 8 session cognitive behavioral therapy for insomnia.

Behavioral: Cognitive-Behavioral Therapy for Insomnia

Good Sleeper

NO INTERVENTION

Good sleeper controls who receive no intervention

Interventions

Cognitive-Behavioral Therapy for Insomnia BEHAVIORAL

Insomnia Subjects receive CBT-I

Also known as: Insomnia Subjects receive CBT-I

Insomnia

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• University of Rochester: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Wilfred R. Pigeon, Ph.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Michael L. Perlis, Ph.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)