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Insomnia Behavioral Therapy for Crohn's Disease (RISE Trial)
RISE Trial Summary
This trial studies if treating insomnia can help improve Crohn's symptoms like pain and inflammation.
RISE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RISE Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with restless leg syndrome.I am currently using opioids for pain management.I have an ileostomy or colostomy.I have been diagnosed with a seizure disorder.I am currently taking corticosteroids.I have been diagnosed with sleep apnea.My sleep and CD medications have been stable for 3 months.I have trouble sleeping and it takes me over 30 minutes to fall asleep or stay asleep.
- Group 1: Behavioral Treatment
- Group 2: Sleep Education Treatment
- 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
Has this medical experiment opened its doors to enrollees yet?
"The clinicaltrial.gov portal indicates that this medical trial has concluded its recruitment phase and is no longer looking for participants. Although it was initially posted on July 26th 2023, the last edit made to the study's page was dated July 13th 2023. Fortunately, there are currently 488 other studies that are actively seeking volunteers to join their research efforts."
What are the main goals of this experiment?
"In order to ascertain the efficacy of the intervention, investigators will monitor primary outcome measures such as recruitment rate over a span of Baseline, 8 weeks, 21 weeks and 34 week. Further assessments include changes in sleep onset latency (a weekly average derived from self-reported diaries) wake after sleep onset (again taken from diary entries). Lastly, Crohn's disease symptom severity is evaluated via Patient Reported Outcomes 3 which runs on a score system ranging from <13 indicating quiescent or inactive disease to 53+ representing severely active condition."
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