Mechanisms of Sleep Disruption Hyperalgesia

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Deprivation, Pain

In brief

Twenty percent of Americans suffer from chronic pain. Sleep disturbance is similarly prevalent and among the most common and disabling neurobehavioral problems associated with chronic pain. This research is designed to evaluate the effects of disrupted sleep patterns on mood, inflammation, the perception of pain, and pain relief. This study will help researchers understand the relationship between sleep and pain, and how sleep disturbance might influence chronic pain conditions.

Key facts

Study ID

NCT01794689

Run by

Johns Hopkins University

People needed

100

Starts

2013-05-01

Expected to finish

2019-03-12

Last updated by the study team

2019-08-02

Who can join

Age: 18 and older, up to 48. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy
• Age 18-48
• Meets Research Diagnostic Criteria for Normal Sleepers
• Stable sleep phase within 21:00 and 08:00
• Total sleep time between 6.5 and 8.5 hours per night
• Sleep efficiency ≥85%
• Epworth Sleepiness Scale Score <10
• Non-smoker/non-nicotine users
• Low Caffeine Users (≤2 cups per day)

You may not qualify if…

• Body Mass Index ≥35
• Lifetime history of chronic pain (>6 months)
• Acute pain
• Significant medical or psychiatric morbidity within 6 months
• Lifetime history of bipolar disorder, psychotic disorder, serious recurrent major depression, serious post-traumatic stress disorder, or seizure disorder
• Respiratory, hepatic, renal, or cardiac conditions that would contraindicate opioid use
• Lifetime history of alcohol or substance abuse or dependence
• Lifetime history of opioid use >36 doses or >7 days of consecutive use
• Prior adverse reaction to general anesthetics, opioids, or capsaicin
• Clinically significant abnormal complete blood count or comprehensive metabolic profile
• Positive toxicology screen for opioids or recreational drugs
• Pregnant or lactating women
• Significant pre-admission psychological distress (T-scores >64 on the Brief Symptom Inventory Global Scales)
• Significant lifetime history of serious head injury that is determined to influence pain processing or sleep systems

Where it is running

• Johns Hopkins University Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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