Clinical trial NCT01794689: Mechanisms of Sleep Disruption Hyperalgesia
Official title: Mechanisms of Sleep Disruption Hyperalgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

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 understand the relationship between sleep and pain, and how sleep disturbance might influence chronic pain conditions. Healthy participants will undergo baseline sleep and sleep disruption conditions. Following undisturbed sleep and sleep disruption conditions, sensitivity to pain and analgesic response (via morphine or placebo administration) will be assessed using a heat-capsaicin pain model.

This study will be conducted in 2 major parts-3 screening visits (2 outpatient and 1 inpatient) and 2 experimental inpatient visits. Part 1 of the study will involve a 1-week screening period. This will involve two separate screening visits lasting about 2 hours each. At Screening Visit 1, participants will complete questionnaires, an interview, and undergo toxicology screening. At Screening Visit 2, participants will complete questionnaires, undergo a physical exam, and be familiarized with pain testing procedures. At Screening Visit 3, participants will undergo an inpatient sleep study.

Part 2 will involve two different inpatient admissions. The two admissions will be separated by at least two weeks. During each of the admissions, participants' sleep will be studied at night. The first admission will begin immediately following the overnight sleep study in Screening Visit 3. One of the admissions will be for one night and the other admission will be for three nights. For the one night admission, participants will sleep undisturbed for an 8-hour period. For the three night admission, participants will undergo sleep disruption for two nights in a row. On the third night, participants will be allowed to sleep undisturbed for 8 hours for recovery.

During both inpatient admissions, pain testing procedures will be completed that will last approximately 5 hours during the day. During testing, small amounts of blood will be drawn for analysis. Participants will be randomly assigned to two groups. Group A will be given a standard dose of morphine during pain testing. Group B will be given a placebo during pain testing.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Spinal Sensitization as Assessed by Area of Secondary Hyperalgesia (2HA) After Two Nights of Uninterrupted Sleep and Two Nights of 8 Forced Awakenings
timeFrame: Next day during quantitative sensory testing after 2 nights of forced awakenings or uninterrupted sleep
Secondary outcomes:
measure: Opioid Analgesia as Assessed by Analgesia Index (Seconds)
timeFrame: Next day after 2 nights of forced awakenings or uninterrupted sleep
measure: Mean Change in Percentage of Peripheral Blood Mononuclear Cells Expressing Interleukin-6 After LPS Stimulation
timeFrame: Next day after 2 nights of forced awakenings or uninterrupted sleep, every 60 minutes up to 7 hours
Other outcomes:
measure: Total Sleep Time
timeFrame: Next day during quantitative sensory testing after 2 nights of forced awakenings or uninterrupted sleep.
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael Smith, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: