Daridorexant for Delirium After Heart Surgery

Overseen By Jabob Nadler, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Sleep aids, Strong 3A4 inhibitors

Disqualifiers: Prior heart surgery, Psychotic disorder, Dementia, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether daridorexant, a sleep aid, can prevent delirium (confusion) after heart surgery. Participants will receive either the study drug or a placebo for the first three nights post-surgery and will be monitored for changes in sleep and delirium. The trial aims to evaluate the effectiveness of the study methods and gather preliminary data for a larger trial. It targets individuals undergoing specific heart surgeries, such as valve replacement or bypass, at Strong Memorial Hospital, who have not previously had heart surgery. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use a sleep aid or a strong 3A4 inhibitor before surgery.

Is there any evidence suggesting that daridorexant is likely to be safe for humans?

Research has shown that daridorexant, a drug tested to prevent confusion after heart surgery, has generally been well-tolerated in past studies. In earlier research, participants taking daridorexant mostly reported mild side effects like headaches and fatigue, with serious side effects being rare.

Since daridorexant is in a Phase 2 trial for this condition, it has already passed initial safety tests in earlier trials. These trials suggest it is safe enough for larger groups. Additionally, daridorexant is already approved for other uses, indicating its likely safety. However, because individuals can react differently, careful monitoring during the study remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for delirium?

Most treatments for delirium after heart surgery focus on managing symptoms with antipsychotics or sedatives. But daridorexant works differently, targeting the sleep-wake cycle by blocking orexin receptors. This unique action might help regulate sleep more naturally, which is crucial for recovery after surgery. Researchers are excited because daridorexant could offer a more precise approach with potentially fewer side effects than traditional medications.

What evidence suggests that daridorexant might be an effective treatment for delirium after heart surgery?

This trial will compare daridorexant with a placebo to evaluate its effectiveness in preventing confusion and disorientation (delirium) after heart surgery. Research suggests that daridorexant, a type of medication, might help by blocking certain signals in the brain that disrupt sleep, and better sleep is believed to reduce delirium. Early results from studies on daridorexant and similar medications have shown promise in improving sleep and lessening the severity of delirium. However, more research is needed to confirm its effectiveness for this specific purpose. ^{1 2 3 6 7}

Who Is on the Research Team?

Mark A Oldham, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for adults who can consent, undergoing aortic valve replacement or bypass surgery at Strong Memorial Hospital, speak English, and have someone close to help with the study. It's not suitable for those unable to meet these conditions.

Inclusion Criteria

Able to speak, read, and write English

Family member or close friend available for collateral

I am having heart valve or bypass surgery at Strong Memorial Hospital.

Exclusion Criteria

Auditory/visual impairment preventing study procedures

I have been diagnosed with infectious endocarditis.

Psychotic disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a baseline visit before surgery

1 day

1 visit (in-person)

Treatment

Participants take the study drug, either daridorexant or placebo, each of the first 3 nights after heart surgery

3 days

Daily evaluations (in-person)

Evaluation

Participants are evaluated for sleep and delirium each of the first three days after heart surgery

3 days

Daily evaluations (in-person)

Follow-up

Participants are monitored for delirium and sleep disturbances, continued up to 1 week if delirious on postoperative day 3

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Daridorexant

Trial Overview The trial tests if Daridorexant helps prevent confusion or 'brain fog' after heart surgery compared to a placebo. Participants take the drug or placebo for three nights post-surgery and are checked for sleep quality and delirium.

How Is the Trial Designed?

Group I: Daridorexant Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Daridorexant is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Quviviq for:

• Insomnia

Approved in European Union as Quviviq for:

• Insomnia

Approved in Canada as Quviviq for:

• Insomnia

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06630390?term=DARIDOREXANT&rank=3

Daridorexant to Prevent Delirium After Heart Surgery 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2667296025004847

A Scoping Review and Feasibility Trial of Daridorexant This report provides a scoping review of the literature on DORAs for delirium and the results of a feasibility trial of daridorexant to prevent delirium after ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40374039/

A Scoping Review and Feasibility Trial of Daridorexant This report provides a scoping review of the literature on DORAs for delirium and the results of a feasibility trial of daridorexant to prevent delirium after ...

4. ctv.veeva.com ctv.veeva.com/study/daridorexant-rct-for-delirium

Daridorexant to Prevent Delirium After Heart Surgery An adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery.

5. researchgate.net researchgate.net/publication/391724318_Dual_orexin_receptor_antagonists_for_delirium_A_scoping_review_and_feasibility_trial_of_daridorexant

A Scoping Review and Feasibility Trial of Daridorexant A double-blinded, randomised, placebo-controlled trial to evaluate the efficacy of suvorexant to improve postoperative sleep and reduce delirium severity in ...

6. app.trialscreen.org app.trialscreen.org/trials/phase-2-daridorexant-rct-delirium-trial-nct06630390

Daridorexant to Prevent Delirium After Heart Surgery Benefits: Your participation in this study may help researchers better understand the potential of daridorexant in preventing delirium after heart surgery.

7. trial.medpath.com trial.medpath.com/clinical-trial/f6fb4c3a33eefdf4/nct06630390-randomized-trial-daridorexant-prevent-delirium-heart-surgery

Daridorexant to Prevent Delirium After Heart Surgery | MedPath In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium ...