POSTOPERATIVE DELIRIUMPhase 2NCT06630390
Daridorexant to Prevent Delirium After Heart Surgery
A Phase 2 study testing Daridorexant 50 mg in people with POSTOPERATIVE DELIRIUM and POSTOPERATIVE COGNITIVE DECLINE, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- POSTOPERATIVE DELIRIUM, POSTOPERATIVE COGNITIVE DECLINE
- What is being tested?
- Daridorexant 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 16 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior heart surgery
- Infectious endocarditis
- Emergency surgery
- Delirium at baseline
- Auditory/visual impairment preventing study procedures
- Active alcohol or substance misuse
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Randomized, Double-blind Trial of 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 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.
- Being tested
- Daridorexant 50 mg, Placebo
- Keywords
- delirium, sleep, cognitive decline, Alzheimer disease and related dementias
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications, Delirium, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daridorexant 50 mgDrug
Administered consistent with labeling from the US Food and Drug Administration.
PlaceboOther
Identical appearing to daridorexant
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant | Experimental | Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery. Receives: Drug: Daridorexant 50 mg |
| Placebo | Placebo comparator | Oral matching placebo each of the first three nights after heart surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium assessments. We aimed to evaluate subjects for delirium on each of the first three days after heart surgery using the Delirium Rating Scale, Revised-98, and the 3-minute Diagnostic Interview for the Confusion Assessment Method. Delirium based on DSM-5-TR diagnostic criteria would be diagnosed using the information from these two assessments. Below we report the number of subjects evaluated on each of the postoperative days.
Measured: First 3 days after surgery
Secondary outcomes (1)
Sleep Disturbance
When evaluating subjects on each of the first 3 days after surgery, we ask subjects to rate their sleep on the preceding night using Richards-Campbell Sleep Questionnaire. This scale includes 6 items (sleep-related domains), each scored using a visual analog scale, ranging from 0 to 100. Higher scores indicate better sleep. Given that this is a feasibility study, we report the number of subjects evaluated for sleep on each of the postoperative days.
Measured: First 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start11 Nov 2024
- Primary completion16 Feb 2025
- Study completion16 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for POSTOPERATIVE DELIRIUMStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the daridorexant or placebo arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Oldham, University of Rochester
- Investigators
- Mark A Oldham, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630390
- Sponsor's protocol ID
- STUDY00009841
- Status last verified
- Jun 2025
- First submitted
- 30 Sep 2024
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This trial is designed to demonstrate feasibility rather than test hypotheses of efficacy. As such, the data that will be obtained would be of very limited value if shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
- ClinicalTrials.gov ID
- NCT06630390
- Acronym / sponsor ID
- STUDY00009841
- Keywords
- delirium, sleep, cognitive decline, Alzheimer disease and related dementias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 16 Feb 2025 (actual)
- Study completion
- 16 Feb 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Posted 11 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the daridorexant or placebo arm.
| Arm | Type | Receives |
|---|---|---|
| Daridorexant | Experimental | Drug: Daridorexant 50 mgOral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery. |
| Placebo | Placebo comparator | Other: PlaceboOral matching placebo each of the first three nights after heart surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Prior heart surgery
- Infectious endocarditis
- Emergency surgery
- Delirium at baseline
- Auditory/visual impairment preventing study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daridorexant 50 mgAdministered consistent with labeling from the US Food and Drug Administration. | Drug | Daridorexant |
| PlaceboIdentical appearing to daridorexant | Other | Placebo |
Primary outcome
Delirium
Time frame: First 3 days after surgery
In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium assessments. We aimed to evaluate subjects for delirium on each of the first three days after heart surgery using the Delirium Rating Scale, Revised-98, and the 3-minute Diagnostic Interview for the Confusion Assessment Method. Delirium based on DSM-5-TR diagnostic criteria would be diagnosed using the information from these two assessments. Below we report the number of subjects evaluated on each of the postoperative days.
1 secondary outcome
Sleep Disturbance
Time frame: First 3 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This trial is designed to demonstrate feasibility rather than test hypotheses of efficacy. As such, the data that will be obtained would be of very limited value if shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Oldham, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daridorexant 50 mg in people with POSTOPERATIVE DELIRIUM and POSTOPERATIVE COGNITIVE DECLINE, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: First 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.