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NCT00680771 · ClinicalTrials.gov registry record

The Psychoneuroimmunology of Insomnia

A clinical trial of Primary Insomnia, sponsored by University of Rochester.

Completed
Registry status
28
Enrollment target
1
Study location

NCT00680771 is a study of Primary Insomnia that has completed, run by University of Rochester. The registered enrollment target is 28 participants, below the 124-participant average among 12 other Primary Insomnia trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00680771, a study of Primary Insomnia, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
28 participants
Enrollment target
1
Study location

Study 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 Studied

Study Locations (1)

New York

  • University of Rochester Sleep Research Laboratory - Rochester

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2008-03
Est. Completion 2010-07

Sponsor

University of Rochester

636 total trials

What the Registry Record Tells You About NCT00680771

The ClinicalTrials.gov registry entry for NCT00680771 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 12 other Primary Insomnia trials with a reported enrollment target (77% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Insomnia appearing as the primary indexed condition, and to 0 interventions.

NCT00680771 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00680771 about?

NCT00680771 is a clinical study titled "The Psychoneuroimmunology of Insomnia". 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 qu...

What is the current status of trial NCT00680771?

This trial is currently completed. The enrollment target is 28 participants. The study started on 2008-03. Estimated completion is 2010-07.

What conditions does trial NCT00680771 study?

This clinical trial studies the following conditions: Primary Insomnia.

Who is sponsoring clinical trial NCT00680771?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00680771 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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