Postoperative Cognitive DeclinePhase 2NCT07217912
Daridorexant to Prevent Post-cardiotomy Delirium
A Phase 2 study testing Daridorexant 50 mg in people with Postoperative Cognitive Decline and Postoperative Delirium, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Decline, Postoperative Delirium
- 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
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- ≥ 60 yrs;
- having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
- can provide consent;
- able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);
- family member or close friend for collateral.
Who cannot join
- Prior cardiotomy
- Infectious endocarditis
- Emergency surgery
- Delirium at baseline (positive 3D-CAM)
- Auditory or visual impairment that prevents study procedures
- Alcohol or substance misuse (CAGE-AID score ≥ 2)
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- Psychotic disorder
- Dementia-level deficits (TICS < 27)
- Use of a prescription sleep aid at least every other night
- Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole)
- Daridorexant intolerance
- Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault <30 mL/min, or on dialysis)
- Narcolepsy
- Suicidal ideation at baseline
- Any condition that, in the PI's opinion, compromises patient safety or data quality
- Additional exclusions for the NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Mark Oldham, MD, 585-275-3592, mark_oldham@urmc.rochester.edu
About this study
Official title: Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting.
Participants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after surgery.
- Being tested
- Daridorexant 50 mg, Placebo
- Keywords
- delirium, sleep, cognitive decline, Alzheimer disease and related dementias
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium, 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 incidence and severity
Participants will be assessed on postoperative days 1-3 using the Delirium Rating Scale, Revised-98 (DRS-R98; range 0-39; higher scores indicate greater severity of delirium symptoms) and 3-minute Diagnostic interview for the Confusion Assessment Method (3D-CAM; 22 dichotomous items used to inform delirium status). Delirium diagnosis is defined per Diagnostic and Manual of Mental Disorders, 5th Edition, Text Revision, and its severity defined as the sum of DRS-R98 score on postoperative days 1-3.
Measured: Postoperative Days 1-3
Secondary outcomes (1)
Postoperative sleep quality
Participants will complete Richards-Campbell Sleep Questionnaire on postoperative days 1-3. This scale includes 6 items (sleep-related domains), each scored using a visual analog scale, ranging from 0 to 100. The total score represents the mean of the first five domain scores. Higher scores indicate better subjective sleep quality.
Measured: Postoperative Nights 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start14 Oct 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DeclineStudies 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 randomly assigned in a 1:1 ratio, stratified by surgery type (SAVR vs CABG) in blocks of 4, to receive either daridorexant or matching placebo on the first three postoperative nights following heart surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Oldham, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217912
- Sponsor's protocol ID
- STUDY000010860
- Status last verified
- Jan 2026
- First submitted
- 14 Oct 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. 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
- NCT07217912
- Acronym / sponsor ID
- STUDY000010860
- Keywords
- delirium, sleep, cognitive decline, Alzheimer disease and related dementias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
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 follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting.
Participants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after 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 randomly assigned in a 1:1 ratio, stratified by surgery type (SAVR vs CABG) in blocks of 4, to receive either daridorexant or matching placebo on the first three postoperative nights following heart surgery.
| 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 (5 listed)
- ≥ 60 yrs;
- having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
- can provide consent;
- able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);
- family member or close friend for collateral.
Key exclusion criteria (16 listed)
- Prior cardiotomy
- Infectious endocarditis
- Emergency surgery
- Delirium at baseline (positive 3D-CAM)
- Auditory or visual impairment that prevents 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 incidence and severity
Time frame: Postoperative Days 1-3
Participants will be assessed on postoperative days 1-3 using the Delirium Rating Scale, Revised-98 (DRS-R98; range 0-39; higher scores indicate greater severity of delirium symptoms) and 3-minute Diagnostic interview for the Confusion Assessment Method (3D-CAM; 22 dichotomous items used to inform delirium status). Delirium diagnosis is defined per Diagnostic and Manual of Mental Disorders, 5th Edition, Text Revision, and its severity defined as the sum of DRS-R98 score on postoperative days 1-3.
1 secondary outcome
Postoperative sleep quality
Time frame: Postoperative Nights 1-3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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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.
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 Cognitive Decline and Postoperative Delirium, 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Oldham, MD (585-275-3592, mark_oldham@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium incidence and severity (time frame: Postoperative Days 1-3). 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 7 Jan 2026.