N/A N=28

The Psychoneuroimmunology of Insomnia

Primary Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT00680771 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Positive Antibody Response — 7; 7 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult · 30+ yrs
Sex: Female
Sponsor: University of Rochester
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Positive Antibody Response	7; 7	—

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.

Eligibility 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) 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00680771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.