N/A N=100 Randomized Double-blind Basic Science

Mechanisms of Sleep Disruption Hyperalgesia

Sleep Deprivation · Pain

Bottom Line

View on ClinicalTrials.gov: NCT01794689 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Spinal Sensitization as Assessed by Area of Secondary Hyperalgesia (2HA) After Two Nights of Uninterrupted Sleep and Two Nights of 8 Forced Awakenings — 1276.25; 1582.67; 1302.93; 1447.9 mm^2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Morphine (Drug); Saline Placebo (Drug); Forced Awakenings (Behavioral); Uninterrupted Sleep (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Spinal Sensitization as Assessed by Area of Secondary Hyperalgesia (2HA) After Two Nights of Uninterrupted Sleep and Two Nights of 8 Forced Awakenings	1276.25; 1582.67; 1302.93; 1447.9	—
SECONDARY Opioid Analgesia as Assessed by Analgesia Index (Seconds)	0.315; 0.156; -0.124; -0.006	—
SECONDARY Mean Change in Percentage of Peripheral Blood Mononuclear Cells Expressing Interleukin-6 After LPS Stimulation	41.98; 51.82; 42.91; 43.32; 45.44; 51.84	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01794689). 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.