Status:
COMPLETED
Mechanisms of Sleep Disruption Hyperalgesia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Sleep Deprivation
Pain
Eligibility:
All Genders
18-48 years
Phase:
NA
Brief Summary
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 resea...
Detailed Description
This research is being conducted in order to evaluate the effects of disrupted sleep patterns on mood, inflammation, the perception of pain, and pain relief. This study will help researchers understan...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01794689
Start Date
May 1 2013
End Date
March 12 2019
Last Update
August 2 2019
Active Locations (1)
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1
Johns Hopkins University Bayview Medical Center
Baltimore, Maryland, United States, 21224