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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 belowSelect...
I have been diagnosed with Type 2 Diabetes.
Select...
I am fluent in Hebrew.
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I am over 65 years old.
Select...
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
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 moreTrial 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.).
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
1,192 Previous Clinical Trials
3,161,816 Total Patients Enrolled
7 Trials studying Diabetes
545 Patients Enrolled for Diabetes
Icahn School of Medicine at Mount SinaiLead Sponsor
868 Previous Clinical Trials
526,973 Total Patients Enrolled
10 Trials studying Diabetes
3,671 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI or PET scan for medical reasons.I have a brain condition like Parkinson's or schizophrenia affecting my thinking.I have a lung condition that makes hyperbaric oxygen therapy unsafe for me.I have been diagnosed with Type 2 Diabetes.I am fluent in Hebrew.I am over 65 years old.I have had surgery for severe cataracts before joining the study.I have been diagnosed with mild cognitive impairment.I have a condition affecting my inner ear.I am taking medication for memory problems.You are afraid of being in small or enclosed spaces.I have had a stroke in the past.I have a history of epilepsy.You have someone who can provide information about you.I am recommended to undergo hyperbaric oxygen therapy.
Research Study Groups:
This trial has the following groups:- Group 1: HBOT intervention
- Group 2: Sham intervention
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Who else is applying?
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
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