CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Morphine +3 moredrug
Likely dose
Morphine 0.08mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01794689
NCT01794689N/ACompleted

Mechanisms of Sleep Disruption Hyperalgesia

Johns Hopkins University·interventional·Posted Feb 20, 2013·Updated Aug 2, 2019

In Brief

A clinical study evaluating Morphine, Saline Placebo, and 2 other interventions for Sleep Deprivation and Pain. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2013
Enrollment StartMay 1, 2013
Primary CompletionJan 1, 2018
Study CompletionMar 12, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.4 years ago

Interventions

Morphinedrug

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).

Saline Placebodrug

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).

Forced Awakeningsbehavioral

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.

Uninterrupted Sleepbehavioral

Participants will receive an 8 hour period of undisturbed sleep