Daridorexant to Prevent Delirium After Heart Surgery

University of Rochester

Status and phase: Completed; Phase 2

Conditions: POSTOPERATIVE DELIRIUM; POSTOPERATIVE COGNITIVE DECLINE

Treatments: Other: Placebo; Drug: Daridorexant 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06630390

STUDY00009841

Details and patient eligibility

About

The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.

Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.

Enrollment: 11 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having surgical aortic valve replacement or coronary artery bypass graft surgery at Strong Memorial Hospital
• Can provide informed consent
• Able to speak, read, and write English
• Family member or close friend available for collateral

Exclusion criteria

• Prior heart surgery
• Infectious endocarditis
• Emergency surgery
• Delirium at baseline
• Auditory/visual impairment preventing study procedures
• Active alcohol or substance misuse
• Psychotic disorder
• Dementia-level deficits
• Use of a sleep aid before surgery
• Use of a strong 3A4 inhibitor
• Intolerance to daridorexant
• Severe kidney or liver impairment
• Narcolepsy
• Any condition that, in the opinion of the PI, compromises patient safety or data quality if enrolled in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Daridorexant

Experimental group

Description:

Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.

Treatment:

Drug: Daridorexant 50 mg

Placebo

Placebo Comparator group

Description:

Oral matching placebo each of the first three nights after heart surgery.

Treatment:

Other: Placebo