Mechanisms of Sleep Disruption Hyperalgesia
NCT01794689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2019-08-02
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.
Conditions
- Sleep Deprivation
- Pain
Interventions
- DRUG
-
Morphine
0.08mg/kg will be administered to participants randomly assigned to receive the drug via IV bolus during each quantitative sensory testing session (after one night of uninterrupted sleep and after 2 nights of forced awakenings).
- DRUG
-
Saline Placebo
Saline Placebo will administered to participants randomly assigned to receive the placebo via IV bolus during each quantitative sensory testing session (after one night of uninterrupted sleep and after 2 nights of forced awakenings).
- BEHAVIORAL
-
Forced Awakenings
Participants will be awakened each hour during an 8 hour sleep opportunity period. One of the awakenings is for 60 minutes and randomly determined. The other 7 awakenings are for 20 minutes each, and are randomly scheduled to occur in either the first second or third tertile of each hour. The maximum total sleep time a participant will receive is 280 minutes.
- BEHAVIORAL
-
Uninterrupted Sleep
Participants will receive an 8 hour period of undisturbed sleep
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH - lead OTHER
Principal Investigators
-
Michael Smith, Ph.D · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 48 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2018-01-31
- Completion
- 2019-03-12
Countries
- United States
Study Locations
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