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Behavioral Intervention
Sleep Health Interventions for Shift Work Sleep Disorder (OSHIN Trial)
N/A
Recruiting
Led By Jessica Dietch, PhD
Research Sponsored by Oregon State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the post-treatment assessment (occurring at approximately 10 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test two methods to help nurses with insomnia from working night shifts.
Who is the study for?
This trial is for night shift working nurses in Oregon who have insomnia or sleep issues and expect to keep their schedule during the study. They must be able to use the internet daily and read/write English. Nurses on certain insomnia treatments, with uncontrolled medical conditions, seizure history, safety risks, or expecting pregnancy can't join.
What is being tested?
The study tests two behavioral strategies for better sleep among nurses working at night: Cognitive Behavioral Therapy for Insomnia (CBTI) and Morning Routine Therapy for Insomnia (MRTI). It aims to see which helps improve sleep quality.
What are the potential side effects?
Since CBTI and MRTI are non-medical interventions focusing on behavior changes rather than drugs, they typically don't have physical side effects. However, participants may experience temporary increases in stress or anxiety as they adjust their routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the post-treatment assessment (occurring at approximately 10 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the post-treatment assessment (occurring at approximately 10 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Insomnia Severity Index
Implementation Assessment Measure
Retention Rate
+1 moreSecondary study objectives
Change in Fatigue Severity Scale
Change in PROMIS Sleep Related Impairment 8 item
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: MRTIExperimental Treatment1 Intervention
Multicomponent Relaxation Therapy for Insomnia
Group II: CBTIExperimental Treatment1 Intervention
Cognitive Behavioral Therapy for Insomnia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBTI
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Monash UniversityOTHER
197 Previous Clinical Trials
10,589,928 Total Patients Enrolled
Stanford UniversityOTHER
2,469 Previous Clinical Trials
17,501,687 Total Patients Enrolled
American Academy of Sleep MedicineOTHER
24 Previous Clinical Trials
2,770 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had seizures or manic episodes in the past.I have severe trouble sleeping.I have been diagnosed with insomnia.I am currently being treated for insomnia.
Research Study Groups:
This trial has the following groups:- Group 1: CBTI
- Group 2: MRTI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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