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Sleep promotion for Insomnia

N/A
Waitlist Available
Led By Randall S Friese, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12, 24, and 48 hours
Awards & highlights
No Placebo-Only Group

Summary

Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse effect of sleep deprivation likely occurs in patients suffering from acute injury and critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated that sleep in ICU patients is highly abnormal. The global hypothesis for this proposal is that a strategy to promote sleep in ICU patients will increase time in rapid eye movement (REM) and slow wave sleep (SWS). This three phase proposal examines the feasibility of a sleep promotion strategy for injured and critically ill patients in the ICU. Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep Enhancement Program (SEP), and train ICU staff. Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety. Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in ICU patients.

Eligible Conditions
  • Insomnia
  • Sleep Deprivation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12, 24, and 48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12, 24, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time in Rapid Eye Movement (REM) Sleep
Time in slow wave sleep
Secondary study objectives
Safety profile
Systemic inflammatory mediators (cytokines)

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
Active Control
Group I: Sleep promotionExperimental Treatment1 Intervention
Measure sleep in ICU with sleep promotion program in effect
Group II: ControlActive Control1 Intervention
Monitor sleep in ICU without attempts at promotion

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
534 Previous Clinical Trials
159,459 Total Patients Enrolled
6 Trials studying Insomnia
372 Patients Enrolled for Insomnia
Arizona Biomedical Research Commission (ABRC)OTHER
2 Previous Clinical Trials
130 Total Patients Enrolled
Randall S Friese, MDPrincipal InvestigatorUniversity of Arizona College of Medicine
~5 spots leftby Nov 2025