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Hormone Therapy

Intranasal Insulin for Post-Surgery Delirium

N/A

Waitlist Available

Research Sponsored by Hiroaki Sato, MD., PhD.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elective open heart surgery requiring cardiopulmonary bypass

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 month

Awards & highlights

Study Summary

This trial is studying whether intranasal insulin during and after heart surgery can help improve cognitive function postoperatively in patients experiencing POCD or POD.

Who is the study for?

This trial is for adults scheduled for elective open heart surgery with cardiopulmonary bypass. Participants must be able to consent, speak English or French, and not have any sensory impairments that affect cognitive testing. It's not suitable for those allergic to insulin or pregnant individuals.Check my eligibility

What is being tested?

The study tests if intranasal insulin can improve memory and cognition after heart surgery, aiming to reduce Postoperative Cognitive Dysfunction (POCD) and Delirium (POD). Patients will receive regular human insulin or a saline solution as a comparison.See study design

What are the potential side effects?

Intranasal insulin may cause local irritation in the nose, low blood sugar levels if absorbed systemically, headache, runny nose, or cough. However, since it's administered nasally rather than injected into the bloodstream directly, systemic side effects are expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for open heart surgery with a heart-lung machine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confusion Assessment method for the ICU

Rey Auditory Verbal Leaning

Rey-Osterrieth Complex Figure Test

Secondary outcome measures

Boston Naming Test

Clock Drawing Test

Stroop Test

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intranasal Insulin 40 IUExperimental Treatment1 Intervention

40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7

Group II: Intranasal Normal SalinePlacebo Group1 Intervention

Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hiroaki Sato, MD., PhD.Lead Sponsor

1 Previous Clinical Trials

141 Total Patients Enrolled

Media Library

Intranasal Insulin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03415061 — N/A

Intranasal Insulin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03415061 — N/A

Heart Disease Research Study Groups: Intranasal Normal Saline, Intranasal Insulin 40 IU

Heart Disease Clinical Trial 2023: Intranasal Insulin Highlights & Side Effects. Trial Name: NCT03415061 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively enrolling participants at the present time?

"At the present moment, this trial is not recruiting new participants. It was first announced on November 1st 2021 and last edited 13 days prior. For those in search of alternative trials, 473 related to delirium are actively seeking applicants while 72 studies concerning Regular Insulin Human 100 UNT/ML are currently enrolling patients."

Answered by AI

Could you elucidate what other research initiatives have been undertaken with Regular Insulin, Human 100 UNT/ML?

"Presently, there are 72 studies ongoing for Regular Insulin, Human 100 UNT/ML with 13 trials in its final phase. A large number of the experiments concerning this medication are based out of Sao Luis, MA yet 248 locations globally have clinical trial programs involving Regular Insulin, Human 100 UNT/ML."

Answered by AI

What is the scope of enrollment for this clinical trial?

"Participants are not being sought out at this time for the clinical trial, which was initialy listed on November 1st 2021 and last modified October 13th 2021. However, if one is looking to join a study there are 473 trials recruiting patients with delirium and 72 trials enrolling those requiring Regular Insulin Human 100 UNT/ML."

Answered by AI

What is the desired outcome of this research?

"This clinical trial, with a 12 month evaluation window, seeks to assess patient's cognitive function using the Confusion Assessment method for the ICU. Secondary objectives include an Information Processing Speed test (Symbol Digit Modalities Test), Visuospatial Function tasks (Clock Drawing Test; scores range from 1-10), and Executive Function exercises (Stroop Test)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Intranasal Insulin on POCD and POD

Hiroaki Sato, MD., PhD. 2021. "Effect of Intranasal Insulin on POCD and POD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03415061.

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