The Psychoneuroimmunology of Insomnia

NCT00680771 | Completed Results

• 2 other identifiers: RSRB # 191321K23NR010408
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Keywords

Primary Insomnia; Insomnia; Good Sleepers; Hep B; Vaccine

Outcome Measures

Primary Outcomes (1)

• Positive Antibody Response

  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.

  3 Months after initial vaccination

Study Arms (2)

1

Primary Insomnia

2

Good Sleepers

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Community Sample

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Rochester Sleep Research Laboratory

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Sample size limited by much higher than expected number of otherwise eligible participants having alrady been exposed to Hep B vaccine or virus.

Results Point of Contact

• Title: Wilfred Pigeon
• Organization: University of rochester

Wilfred_pigeon@urmc.rochester.edu

(585) 275-3374

Study Officials

• Wilfred R Pigeon, Ph.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 20, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 17, 2012
• Results First Posted: October 17, 2012

Record last verified: 2012-09

Locations

US (1)