Mechanisms of Sleep Disruption Hyperalgesia (ESP2)
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|ClinicalTrials.gov Identifier: NCT01794689|
Recruitment Status : Recruiting
First Posted : February 20, 2013
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Deprivation Pain||Drug: Morphine Drug: Saline Placebo (for Morphine)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Basic Science|
|Official Title:||Mechanisms of Sleep Disruption Hyperalgesia|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Participants randomized to receive Morphine will receive the injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session.
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).
Placebo Comparator: Saline Placebo
Participants randomized to receive the saline placebo will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session.
Drug: Saline Placebo (for Morphine)
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).
- Effects of experimental sleep disruption on spinal sensitization via laboratory pain responses in a heat-capsaicin pain model. [ Time Frame: Next day after 2 nights of forced awakenings. ]Spinal sensitization will be assessed during quantitative sensory testing by measuring primary hyperalgesia and secondary hyperalgesia.
- Effects of experimental sleep disruption on opioid analgesia. [ Time Frame: Next day after 2 nights of forced awakenings. ]After 2 nights of forced awakenings, opioid analgesia will be assessed by measuring primary hyperalgesia, secondary hyperalgesia, and cold pressor pain tolerance.
- Effects of sleep disruption on cellular and genomic markers of inflammation and characterization of inflammatory activity on laboratory pain responses and opioid analgesia. [ Time Frame: Next day after 2 nights of forced awakenings during quantitative sensory testing; 4 hours pre-morphine administration and 2 hours post-morphine administration. ]After 2 nights of forced awakenings, during quantitative sensory testing, blood will be drawn pre-and post-morphine/placebo administration to examine markers of inflammation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794689
|Contact: Mercedes Robinson||(410) firstname.lastname@example.org|
|Contact: Michelle Polleyemail@example.com|
|United States, Maryland|
|Johns Hopkins University Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Mercedes Robinson, B.S. 410-550-7912 firstname.lastname@example.org|
|Contact: Michelle Polley, BA 4105507000 email@example.com|
|Principal Investigator: Michael T. Smith, Ph.D|
|Principal Investigator:||Michael Smith, Ph.D||Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences|