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Sleep Disturbance + Study Drug for Sleep Disorders (Sleep-MOR Trial)
Sleep-MOR Trial Summary
This trial is looking at whether sleep disturbance alters the way people respond to pain medication and whether it makes the medication more likely to be abused.
Sleep-MOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Sleep-MOR Trial Design
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Who is running the clinical trial?
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- My BMI is over 35.I am currently experiencing severe pain.You feel uncomfortable in small, enclosed spaces.You have a history of alcohol or drug addiction.You have metal objects or electronic devices in your body that could be unsafe during an MRI.You have tested positive for opioids or recreational drugs in a drug test.I have not had significant health or mental health issues in the past 6 months, nor do I have a history of bipolar, psychotic disorders, or seizures.I have had a head injury that made me unconscious for more than 3 minutes.You drink two cups of coffee or less per day.I have experienced chronic pain for a long time.I have not used antidepressants, sedatives, or similar drugs in the last 3 months.I do not have major brain or nerve diseases like lupus or MS.I have been experiencing significant emotional or mental distress before being admitted.You sleep between 6.5 and 8.5 hours per night and have a sleep efficiency of at least 85%.You have taken opioids for pain in the past.You drink two or fewer cups of caffeine per day.You have a significant abnormality in your blood count, liver, kidney, or metabolic tests.I am between 18 and 48 years old and have normal sleep patterns.You sleep between 9:00 PM and 8:00 AM.I have been diagnosed with a sleep disorder.You do not smoke or use nicotine products.You have taken opioids prescribed for pain for a long time.I have been exposed to high levels of radiation before this study.
- Group 1: Sleep Continuity Disruption
- Group 2: Sleep Fragmentation
- Group 3: Undisturbed Sleep
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
The elderly are sometimes more susceptible to adverse effects, is this study open to patients who fall into that age bracket?
"This trial is for adults aged 18 to 48. There are 80 other trials targeting patients below the age of 18 and 463 for seniors."
Are patients currently being accepted for this trial?
"Yes, the trial is recruiting patients as of now. The clinical trial was posted on November 11th, 2020 and updated on November 14th, 2022. They are looking for 200 participants from 1 site."
Might I be eligible to join this research project?
"To be eligible for this sleep study, candidates must be between 18-48 years old, have a reported healthy sleep schedule (hs), and meet the following additional requirements: get more than 6.5 but no more than 8.5 hours of sleep per night; have a nightly sleep efficiency of at least 85%; be non-smokers/nicotine users and low caffeine users (2 cups or less per day)."
How many people are the investigators enrolling in this research project?
"That is accurate. The clinicaltrials.gov website has information indicating that this trial is currently admitting patients. It was originally posted on November 11th, 2020 and most recently updated on November 14th, 2022. Currently, 200 participants are being recruited at 1 location."
Could you elaborate on the risks of Sleep Continuity Disruption to patients?
"Since this is a phase 2 trial, meaning that while there are some data supporting safety, there are no data supporting efficacy, our team has estimated the safety of Sleep Continuity Disruption to be a 2."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Johns Hopkins School of Medicine: < 48 hours
Average response time
- < 2 Days
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