The Psychoneuroimmunology of Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680771
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : October 17, 2012
Last Update Posted : October 17, 2012
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Wilfred Pigeon, University of Rochester

Brief Summary:

Chronic insomnia affects approximately 8-9% of the population. The prevalence of this disorder rises dramatically across the lifespan, especially so in women. When it is chronic, insomnia is associated with increased fatigue, cognitive impairment, mood disturbance, physical complaints, diminished quality of life and increased health care consumption. There is also more limited evidence (based on epidemiologic studies or experimental studies in healthy subjects) that insomnia and/or sleep loss may be a risk factor for hypertension and/or cardiovascular disease and increased mortality.

Despite its prevalence and consequences, the pathophysiology of insomnia and, specifically, the pathway by which morbidity risk is conferred, has been relatively unstudied. With respect to medical illness in particular, insomnia may confer risk in several ways, including: 1) an inherent compromise in the restorative/conservative function of sleep, 2) the deleterious effects of "hyperarousal" and/or HPA axis abnormalities on end organ integrity and function, and/or 3) diminished immunocompetence. This study focuses on the last of these possibilities, the relationship between immune function and sleep.

The study compares immune response to a vaccine challenge in two groups: good sleepers and patients with chronic insomnia. The primary study hypothesis is that the insomnia group will have a decreased rate of adaptive immune response to the vaccine challenge than that of the good sleeper group.

Condition or disease
Primary Insomnia

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Psychoneuroimmunology of Insomnia: Response to a Vaccine Challenge
Study Start Date : March 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Primary Insomnia
Good Sleepers

Primary Outcome Measures :
  1. Positive Antibody Response [ Time Frame: 3 Months after initial vaccination ]
    Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community Sample

Inclusion Criteria:

Their sleep schedule will include a typical bedtime of between 9:00 p.m. and 12:00 a.m. to minimize circadian rhythm influences on the diagnoses of Primary Insomnia (PI).

PIs will also meet the sleep disturbance criteria of the Pittsburgh Sleep Quality Index(PSQI) > 5 and the Insomnia Severity Index (ISI)> 15 and one of the following minimal characteristics both at intake and as an average profile from the two weeks of baseline diaries: > 30 min. sleep-onset latency (SL), > 30 min. of wake after sleep-onset (WASO), Early Morning Awakening >30 min. prior to the desired wake up time, or any two of the above complaints (Mixed Insomnia); Total Sleep Time (TST) < 6 hours [unless the Sleep Efficiency is < 80%] and the problem frequency must be > 3 nights/week; problem duration > 6 months.

Good Sleeper participants will report that they obtain enough sleep and that their sleep is restorative with average SL and WASO < 15 minutes, TST > 6 hours ESS < 5 on the ESS, < 5 on the PSQI, and < 7 on the ISI.

Exclusion Criteria for All Subjects

  • any conditions contraindicated by the vaccine manufacturer or any history of allergic reactions to vaccines
  • Undergoing and/or taking immunosuppressive therapies
  • Sero-positive for Hep B antibodies
  • Inadequate language comprehension
  • Menopause, peri-menopause or premenstrual syndrome
  • Pregnancy
  • Unstable medical or psychiatric illness
  • History of head injury with a sustained loss of consciousness
  • Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
  • Use of medications thought to alter sleep such as stimulants, sedating antidepressants, and hypnotics
  • Symptoms suggestive of sleep disorders other than Insomnia
  • Polysomnographic data indicating sleep disorders other than Insomnia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680771

United States, New York
University of Rochester Sleep Research Laboratory
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Nursing Research (NINR)
Principal Investigator: Wilfred R Pigeon, Ph.D. University of Rochester

Responsible Party: Wilfred Pigeon, Assistant Professor of Psychiatry, University of Rochester Identifier: NCT00680771     History of Changes
Other Study ID Numbers: RSRB # 19132
1K23NR010408 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2008    Key Record Dates
Results First Posted: October 17, 2012
Last Update Posted: October 17, 2012
Last Verified: September 2012

Keywords provided by Wilfred Pigeon, University of Rochester:
Primary Insomnia
Good Sleepers
Hep B

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders