Delirium - PostoperativePhase 2/3INSPIRENCT07532577
Intranasal Insulin to Prevent Intensive Care Unit Delirium
A Phase 2/3 study testing Intranasal insulin-40U and Intranasal sodium chloride 0.9% in people with Delirium - Postoperative, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium - Postoperative
- What is being tested?
- Intranasal insulin-40U and Intranasal sodium chloride 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Apr 2026to 30 Jul 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years
- Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG
- Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
- Informed consent from patient
Who cannot join
- Delirium at hospital admission
- Non-complex or off-pump cardiac surgery
- Known allergy/hypersensitivity to insulin or formulation excipients
- Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
- Participating in other investigational medication trial
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA
About this study
Official title: Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)
This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass
- Conditions
- Delirium - Postoperative
- Being tested
- Intranasal insulin-40U, Intranasal sodium chloride 0.9%
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal insulin-40UDrug
Intranasal isophane insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.
Intranasal sodium chloride 0.9%Drug
Intranasal sodium chloride 0.9% administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4mL per day.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal insulin | Experimental | Intranasal insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day. Receives: Drug: Intranasal insulin-40U |
| Intranasal placebo (NaCl 0.9%) | Placebo comparator | Intranasal placebo (sodium chloride 0.9%) administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4 mL per day. Receives: Drug: Intranasal sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: rate of recruitment
Proportion of eligible patients who are enrolled and randomized during the recruitment period.
Measured: From start of study to end of study, with a maximum of 12 months
Feasibility: protocol adherence
Number of administered doses divided by number of planned doses
Measured: From start of treatment up to a maximum of 5 days
Feasibility: participant retention and follow-up completeness
Proportion of randomized participants completing in-hospital data collection and 30-day follow-up (TICS-m).
Measured: From start of study to end of study, with a maximum of 12 months
Tolerability
- Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia (mild: glucose <4.1 mmol/L, severe: <2.2 mmol/L), defined as the number of local nasal adverse events and hypoglycaemia events.
Measured: From start of treatment up to a maximum of 5 days
Exploratory efficacy
Delirium severity as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98)
Measured: From start of treatment up to a maximum of 7 days
Secondary outcomes (8)
Delirium incidence
Defined as >= 1 positive delirium assessment(s)
Measured: From start of treatment up to a maximum of 7 days
Delirium severity
Numeric, as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98)
Measured: From start of treatment up to a maximum of 7 days
Delirium duration
Defined as number of days with positive delirium assessment
Measured: From start of treatment up to a maximum of 7 days
Delirium and coma-free days
Defined as the number of days without delirium or coma
Measured: From start of treatment up to a maximum of 7 days
Exposure to antipsychotics, sedatives and benzodiazepines
Defined as the number of patients receiving antipsychotics, sedatives, or benzodiazepines
Measured: From start of treatment up to a maximum of 7 days
Length of ICU stay
Defined as days spent in the ICU
Measured: From ICU admission to ICU discharge, assessed up to 6 months
Length of hospital stay
Defined as days spent in the hospital
Measured: From hospital admission to discharge, assessed up to 6 months
Change in cognitive function
Assessed with the modified Telephone Interview for Cognitive Status (TICS-m) at baseline (before hospital admission) and 30 days after surgery
Measured: From informed consent to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start30 Apr 2026
- Primary completion15 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled pilot trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532577
- Sponsor's protocol ID
- 2025-524680-21-00
- Other IDs
- 2025
- Acronym
- INSPIRE
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)
- ClinicalTrials.gov ID
- NCT07532577
- Acronym / sponsor ID
- INSPIRE / 2025-524680-21-00
- Conditions
- Delirium - Postoperative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 16 Apr 2026 (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.
This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass
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
- Randomized, double-blind, placebo-controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Intranasal insulin | Experimental | Drug: Intranasal insulin-40UIntranasal insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day. |
| Intranasal placebo (NaCl 0.9%) | Placebo comparator | Drug: Intranasal sodium chloride 0.9%Intranasal placebo (sodium chloride 0.9%) administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4 mL per day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥65 years
- Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG
- Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
- Informed consent from patient
Key exclusion criteria (5 listed)
- Delirium at hospital admission
- Non-complex or off-pump cardiac surgery
- Known allergy/hypersensitivity to insulin or formulation excipients
- Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
- Participating in other investigational medication trial
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 |
|---|---|---|
| Intranasal insulin-40UIntranasal isophane insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day. | Drug | Intranasal insulin |
| Intranasal sodium chloride 0.9%Intranasal sodium chloride 0.9% administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4mL per day. | Drug | Intranasal placebo (NaCl 0.9%) |
Primary outcome
Feasibility: rate of recruitment
Time frame: From start of study to end of study, with a maximum of 12 months
Proportion of eligible patients who are enrolled and randomized during the recruitment period.
Feasibility: protocol adherence
Time frame: From start of treatment up to a maximum of 5 days
Number of administered doses divided by number of planned doses
Feasibility: participant retention and follow-up completeness
Time frame: From start of study to end of study, with a maximum of 12 months
Proportion of randomized participants completing in-hospital data collection and 30-day follow-up (TICS-m).
Tolerability
Time frame: From start of treatment up to a maximum of 5 days
- Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia (mild: glucose <4.1 mmol/L, severe: <2.2 mmol/L), defined as the number of local nasal adverse events and hypoglycaemia events.
Exploratory efficacy
Time frame: From start of treatment up to a maximum of 7 days
Delirium severity as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98)
8 secondary outcomes
Delirium incidence
Time frame: From start of treatment up to a maximum of 7 days
Delirium severity
Time frame: From start of treatment up to a maximum of 7 days
Delirium duration
Time frame: From start of treatment up to a maximum of 7 days
Delirium and coma-free days
Time frame: From start of treatment up to a maximum of 7 days
Exposure to antipsychotics, sedatives and benzodiazepines
Time frame: From start of treatment up to a maximum of 7 days
Length of ICU stay
Time frame: From ICU admission to ICU discharge, assessed up to 6 months
Length of hospital stay
Time frame: From hospital admission to discharge, assessed up to 6 months
Change in cognitive function
Time frame: From informed consent to 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. Upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intranasal insulin-40U and Intranasal sodium chloride 0.9% in people with Delirium - Postoperative, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 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 3 Aug 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 Netherlands. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: rate of recruitment (time frame: From start of study to end of study, with a maximum of 12 months). The study lists 5 primary outcomes in all. 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 3 Aug 2026.