The Psychoneuroimmunology of Insomnia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wilfred Pigeon, University of Rochester
ClinicalTrials.gov Identifier:
NCT00680771
First received: May 15, 2008
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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
Primary Insomnia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Psychoneuroimmunology of Insomnia: Response to a Vaccine Challenge

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Positive Antibody Response [ Time Frame: 3 Months after initial vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: March 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Primary Insomnia
2
Good Sleepers

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Community Sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680771

Locations
United States, New York
University of Rochester Sleep Research Laboratory
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Wilfred R Pigeon, Ph.D. University of Rochester
  More Information

Additional Information:
No publications provided

Responsible Party: Wilfred Pigeon, Assistant Professor of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT00680771     History of Changes
Other Study ID Numbers: RSRB # 19132, 1K23NR010408
Study First Received: May 15, 2008
Results First Received: September 26, 2011
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Primary Insomnia
Insomnia
Good Sleepers
Hep B
Vaccine

ClinicalTrials.gov processed this record on October 16, 2014