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HBOT for Dementia in Diabetic Elderly

N/A

Recruiting

Led By Mary Sano, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Diagnosis of T2D

Hebrew fluency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

Study Summary

This trial will investigate if hyperbaric oxygen therapy can help with mild cognitive impairment and dementia in elderly diabetes patients.

Who is the study for?

This trial is for diabetic elderly over 65 with mild cognitive impairment who speak Hebrew and have someone to inform about their condition. It's not for those with inner ear issues, claustrophobia, certain medication use, prior HBOT indication, severe cataracts without surgery, stroke history, other brain diseases affecting cognition like Parkinson's or schizophrenia, epilepsy history, chest problems preventing HBOT use or MRI/PET scan contraindications.Check my eligibility

What is being tested?

The study tests hyperbaric oxygen therapy (HBOT) against a sham intervention to see if it improves thinking abilities and blood flow in the brain of diabetic elders at risk of dementia. Participants are randomly assigned to one of the two groups to compare short-term and long-term effects.See study design

What are the potential side effects?

Possible side effects from HBOT may include temporary vision changes due to eye pressure adjustments; ear discomfort or sinus pain from pressure changes; fatigue; headache; and rarely more serious risks such as lung collapse or seizures.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Type 2 Diabetes.

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I am fluent in Hebrew.

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I am over 65 years old.

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I have been diagnosed with mild cognitive impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Cognitive outcome

Secondary outcome measures

ADL questionnaire

CDR-SB

Change in secondary cognitive outcomes

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HBOT interventionExperimental Treatment1 Intervention

The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 30 minutes.

Group II: Sham interventionPlacebo Group2 Interventions

Except for pressure, all the conditions of the HBOT intervention are provided in the sham intervention (nurse measures vitals and asks about health before entering the chamber, time in the chamber, number of sessions per week and overall, nurse in the chamber at all times, mask on the face, etc.).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Assaf-Harofeh Medical CenterOTHER_GOV

263 Previous Clinical Trials

90,857 Total Patients Enrolled

5 Trials studying Diabetes

344 Patients Enrolled for Diabetes

University of Wisconsin, MadisonOTHER

1,189 Previous Clinical Trials

3,169,392 Total Patients Enrolled

7 Trials studying Diabetes

545 Patients Enrolled for Diabetes

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

525,122 Total Patients Enrolled

10 Trials studying Diabetes

3,671 Patients Enrolled for Diabetes

Media Library

HBOT intervention (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03036254 — N/A

Diabetes Research Study Groups: HBOT intervention, Sham intervention

Diabetes Clinical Trial 2023: HBOT intervention Highlights & Side Effects. Trial Name: NCT03036254 — N/A

HBOT intervention (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03036254 — N/A

Frequently Asked Questions

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

Does this research study have open enrollment at present?

"According to the latest information on clinicaltrials.gov, this research study is actively enrolling participants. This trial was initially launched in October 2017 and has been revised for accuracy April 7th 2022."

Answered by AI

How many test subjects are engaged in this clinical experiment?

"Yes, the data available on clinicaltrials.gov reveals that recruitment is underway for this research initiative. It was posted in October 2017 and recently edited in April 2022; 154 participants are being sought from two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk

Michal Beeri 2017. "Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03036254.