Orexin Receptor Antagonist in Hospitalized Patients With Cancer to Prevent Delirium

Overview

About this study

The purpose of this study is to use suvorexant in addition to standard delirium precautions in hospitalized adults with insomnia and risk factors for delirium will produce a significant reduction in delirium incidence and severity compared to standard delirium precautions alone

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Hospitalized adults age 18 or above.
  • Age 75 or above.
  • Hearing impairment.
  • Vision impairment.
  • Initiation of 8 or new medications since start of hospitalization.
  • Chronic kidney disease III or greater.
  • Congestive heart failure.
  • Hospitalization for 14 or more days.
  • Dehydration requiring ongoing use of IV hydration.
  • Electrolyte imbalance requiring ongoing correction.

Exclusion Criteria: 

  • Inability to consent.
  • Current pregnancy.
  • Current or prior delirium in the active hospitalization.
  • Use of -azole antifungals.
  • Use of any benzodiazepine, benzodiazepine receptor modulator, or first generation antihistamine class medication within 72 hours prior to enrollment.
  • Personal history of narcolepsy.
  • Personal history of other primary sleep disorders including obstructive sleep apnea.
  • Personal history of alcohol use disorder.
  • Personal history of substance use disorder.
  • Personal history of cirrhosis.
  • Transaminitis more than 3 times the upper limit of normal.
  • History of obstructive lung disease other than asthma.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/28/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Regina Mackey, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20578194

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