Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients
NCT06834386 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2025-05-01
Summary
This phase IV trial compares suvorexant with standard of care to standard of care alone for improving difficulty sleeping (insomnia) and reducing confusion (delirium) in hospitalized cancer patients. Delirium can lengthen hospitalization, increase the delay of cancer treatment and can even increase the risk of premature death. Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness. Giving suvorexant with standard of care to treat insomnia may be more effective compared to standard of care alone in reducing the development of delirium in hospitalized cancer patients.
Conditions
- Advanced Malignant Solid Neoplasm
- Delirium
- Hematopoietic and Lymphatic System Neoplasm
- Insomnia
Interventions
- OTHER
-
Best Practice
Receive standard of care
- OTHER
-
Electronic Health Record Review
Ancillary studies
- OTHER
-
Interview
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- DRUG
-
Suvorexant
Given PO
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Regina M. Mackey, MD · Mayo Clinic in Rochester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-26
- Primary Completion
- 2025-04-24
- Completion
- 2025-04-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
NCT01021813 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
NCT01097616 ·Status: COMPLETED ·Phase: PHASE3
-
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
NCT03642028 ·Status: RECRUITING ·Phase: PHASE4
-
REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant
NCT05733286 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
NCT03034018 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
NCT06655883 ·Status: RECRUITING ·Phase: PHASE3
-
Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
NCT05908526 ·Status: COMPLETED ·Phase: PHASE2
-
Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia
NCT05593653 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
NCT07082829 ·Status: RECRUITING ·Phase: PHASE1
-
Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
NCT02491788 ·Status: COMPLETED ·Phase: PHASE4
-
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
NCT00792298 ·Status: COMPLETED ·Phase: PHASE2
-
Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
NCT06093126 ·Status: RECRUITING ·Phase: PHASE4
-
Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)
NCT06584942 ·Status: RECRUITING ·Phase: PHASE4
-
A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.
NCT06823752 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
NCT04706091 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study
NCT00464243 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
NCT00784875 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
NCT03375203 ·Status: COMPLETED ·Phase: PHASE2
-
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
NCT02849548 ·Status: COMPLETED ·Phase: PHASE4
-
Suvorexant and Trauma Related Insomnia
NCT02704754 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
NCT03626727 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
NCT01019187 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
NCT03679884 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL
NCT00236080 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia
NCT06053840 ·Status: COMPLETED ·Phase: PHASE4