Diabetes MellitusNCT03036254
Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk
A study testing HBOT intervention in people with Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai at 4 sites in 2 countries.
Trial summary
An urgent need exists to identify effective interventions to arrest or reverse dementia and cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive functioning, cerebral blood flow, and glucose uptake… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- HBOT intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Aug 2017to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of T2D
- Diagnosis of MCI
- > the age of 65
- Hebrew fluency
- An informant
Who cannot join
- Brain disease that affects cognition (e.g. Parkinson's disease, schizophrenia).
- Stroke
- Epilepsy
- Chest pathology incompatible with HBOT
- Inner ear disease
- Claustrophobia
Show all 10Show fewer
- Cholinesterase inhibitors
- Subjects with an indication for HBOT
- Counter-indication for MRI or PET
- Individuals with severe cataracts must have cataract operations before enrolling in the study
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
University of Wisconsin
Madison, Wisconsin, 53076
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Israel2 sites
Sheba Medical Center
Ramat Gan
Assaf HaRofeh Medical Center
Tzrifin, 70300
About this study
An urgent need exists to identify effective interventions to arrest or reverse dementia and cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen therapy effects on cognition in diabetes. The potential to preserve, or even enhance, cognition in elderly at high risk of cognitive decline and dementia has major implications for the affected individuals and their support systems that bear the social and financial burdens of long-term caregiving.
Read the detailed description
This resubmission responds to "PAR-16-365-Pilot Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)". It will examine the efficacy of hyperbaric oxygen therapy (HBOT) in improving cognitive functioning in cognitively impaired elderly with diabetes (T2D), who have high risk for dementia. It is a collaboration of the Icahn School of Medicine at Mount Sinai, NY, the University of Wisconsin, the Sagol Center for Hyperbaric Medicine and Research at Asaf Harofeh Medical Center, Israel-one of the world's largest and busiest hyperbaric units-and the Sheba Medical Center, Israel.
HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure above the ambient atmosphere. The combined action of hyperoxia and hyperbaric pressure leads to significant improvements in tissue oxygenation, resulting in cerebrovascular benefits with improved ischemic damage and cerebral blood flow. Recently, the researchers of this group published compelling evidence from clinical trials indicating HBOT neurotherapeutic effects in stroke, with better cognitive function and elevated brain activity in SPECT. New preliminary data suggests potential neurotherapeutic effects of HBOT on T2D elderly with mild cognitive impairment (MCI), showing better cognitive performance and brain activity. The researchers propose a randomized controlled clinical trial examining the short (12 weeks) and long-term (12 months) efficacy of HBOT. The researchers will test hypotheses that HBOT compared to a sham condition improves cognitive function and increases cerebral blood flow and glucose utilization in MCI patients with T2D. Such patients are at high dementia risk and enriched in cerebrovascular disease, and thus have high potential for benefitting from HBOT. Aim 1 examines the potential beneficial effects of HBOT on cognition (with a primary composite measure of executive functions and episodic memory, both affected by T2D). Aim 2 examines effects of HBOT on ischemic injury which will be measured by CBF at the level of capillaries in gray matter (by MRI arterial spin labeling), and in macrovessels (by a novel 4D Flow MRI technology developed by the researchers of this group). Aim 3 focuses on effects of HBOT on cerebral glucose utilization using [F18]FDG-PET. Finally, Aim 4 investigates mediation by the biomarkers, i.e. whether their inclusion in a mediation model will attenuate the effect of HBOT on cognition, suggesting them as underlying mechanisms. This study will be performed in Israel, where there is optimal infrastructure and expertise for all the study components at significantly lower costs. HBOT can be widely deployed in the US so if successful, this pilot study will provide the basis for a multi-center large-scale clinical trial for definitive evidence of its benefits to cognition in T2D patients at high dementia risk. Despite advances in the understanding of risk factors and the pathologic basis for dementia, treatments are of very limited effects. As the proportion of elderly increases, the accelerating prevalence of T2D and dementia amplifies this application's public health impact.
- Conditions
- Diabetes Mellitus
- Being tested
- HBOT intervention, Sham intervention
- Keywords
- Diabetes Mellitus, Cognition
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOT interventionDevice
Also called Hyperbaric oxygen therapy
HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure.
HBOT intervention arm - 3 months of HBOT treatment, 9 months observation
all participants receive HBOT treatment for 3 months at year 2
Sham interventionDevice
Sham was selected as the control condition rather than "usual care" to equate intervention groups with respect to other variables that could influence cognition and functional status, such as a new challenge (completing an activity program), peer socialization, and attention from staff.
| Study group | Role | What they receive |
|---|---|---|
| HBOT intervention | Experimental | 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. Receives: Device: HBOT intervention |
| Sham intervention | Sham comparator | 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.). Receives: Device: HBOT intervention; Device: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Cognition Score
This analysis involves 11 cognitive performance variables, each measuring a specific aspect of cognition. In general, higher scores indicate better performance (Digit Symbol measures processing speed, Semantic Fluency measures verbal fluency, Word Recall Task measures immediate verbal memory, Delayed Word Recall Test measures delayed verbal memory, and Recall Unit measures immediate and delayed story recall), except for two variables (Trail Making Test Part A measures processing speed, Trail Making Test Part B measures cognitive flexibility) that measure time (where higher values indicate worse performance). These variables are standardized using Z-scores, which allow for combining and comparing values across different scales.
The standardized values (Z-scores) of all 11 measures are averaged to create the composite score. Full range of composite score is -1 to 1. Higher composite Z-score reflects better cognitive performance and more favorable outcomes.
Measured: baseline, 12, weeks, 6 months and 12 months
Cerebral Blood Flow
Cerebral blood flow (CBF) via arterial spin labeling magnetic resonance imaging (ASL-MRI). CBF is defined as the blood volume that flows per unit mass per unit time in brain tissue.
Measured: baseline, 3 months, and 12 months
Whole Brain SUVr (FDG-PET)
Measures how actively the brain uses glucose, highlighting areas with abnormal activity that may signal diseases like Alzheimer's. Dimmer areas suggest reduced activity seen in disorders like dementia.
Measured: Baseline, 12 weeks, 12 months
Secondary outcomes (6)
NIH Computerized Cognitive Test
The sum z-scores for 3 computer-based tests (not language dependent), developed through NIH; EXAMINER assessing executive abilities: http://examiner.ucsf.edu).
Early in the study, it became clear that participants-older adults with significant frailty, multiple chronic conditions (average >4 per participant), and high medication burden (mean >5 medications)-were finding the assessment protocol burdensome.
The protocol already required repeated cognitive testing, MRI, FDG-PET imaging, and other assessments, leading many participants to report fatigue and difficulty concentrating. To prioritize participant well-being, decision made not to add the NIH computerized cognitive tests. The existing paper-and-pencil battery was well-established, sensitive to cognitive changes, and adequately covered executive function and episodic memory.
The NIH computerized cognitive test was never administered, and no data was collected at any time.
Measured: Baseline, 12 weeks, 6 months, 12 months
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Clinical Dementia Rating-Sum of Boxes (CDR-SB), which summarizes impairment in 6 domains (memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care) based on subject and informant interviews. Scores in each of these are combined to obtain a composite score ranging from 0 (no symptoms of dementia) through 3 (severe symptoms of dementia).
Total scale from 0-18. Higher scores indicating worse cognitive status.
Measured: baseline, 12, weeks, 6 months and 12 months
Beck Depression Inventory (BDI)
This is a 21-item, self-report questionnaire that measures attitudes and symptoms of depression during the last week (i.e. mood, feelings of hopelessness, failure, guilt, self-esteem, etc.). Each question has a set of at least four possible responses, ranging in intensity. Total scale 0-63. Higher scores indicate more severe symptoms of depression.
Measured: baseline, 12 weeks, 6 months and 12 months
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI)
ADL questionnaire Participant
The ADL-PI was developed, comprising 15 ADL (e.g. managing medications, managing finances) and 5 physical function (e.g. shopping and meal preparation) questions. All responses relate to the 3 months prior to the time of rating.
Total range 0-30, higher scores indicate greater impairment.
Measured: baseline, 12 weeks, 6 months, and 12 months
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI)
ADL Informant
This tool is based on caregiver's report to assess participants' abilities to perform basic and instrumental activities of daily living (ADLs) like bathing, walking and self-grooming. All responses should relate to the 4 weeks prior to the time of rating. Full Scale range from 0-53, higher score indicates more impairment for the participant.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Total Mini-Mental State Examination (MMSE)
Total range 0-30, higher scores indicate better cognitive function.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start10 Aug 2017
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center, Assaf-Harofeh Medical Center, University of Wisconsin, Madison
- Responsible party
- Principal investigator, Michal Beeri, Icahn School of Medicine at Mount Sinai
- Investigators
- Michal Schnaider-Beeri, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiMary Sano, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036254
- Sponsor's protocol ID
- GCO 15-0192
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2017
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified MRI and PET scans and cognitive scores will be made available for investigative collaborations. We expect to share these data with a large number of investigators throughout the world.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk
- ClinicalTrials.gov ID
- NCT03036254
- Acronym / sponsor ID
- GCO 15-0192
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Sheba Medical Center, Assaf-Harofeh Medical Center, University of Wisconsin, Madison
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An urgent need exists to identify effective interventions to arrest or reverse dementia and cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen therapy effects on cognition in diabetes. The potential to preserve, or even enhance, cognition in elderly at high risk of cognitive decline and dementia has major implications for the affected individuals and their support systems that bear the social and financial burdens of long-term caregiving.
Detailed description
This resubmission responds to "PAR-16-365-Pilot Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)". It will examine the efficacy of hyperbaric oxygen therapy (HBOT) in improving cognitive functioning in cognitively impaired elderly with diabetes (T2D), who have high risk for dementia. It is a collaboration of the Icahn School of Medicine at Mount Sinai, NY, the University of Wisconsin, the Sagol Center for Hyperbaric Medicine and Research at Asaf Harofeh Medical Center, Israel-one of the world's largest and busiest hyperbaric units-and the Sheba Medical Center, Israel.
HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure above the ambient atmosphere. The combined action of hyperoxia and hyperbaric pressure leads to significant improvements in tissue oxygenation, resulting in cerebrovascular benefits with improved ischemic damage and cerebral blood flow. Recently, the researchers of this group published compelling evidence from clinical trials indicating HBOT neurotherapeutic effects in stroke, with better cognitive function and elevated brain activity in SPECT. New preliminary data suggests potential neurotherapeutic effects of HBOT on T2D elderly with mild cognitive impairment (MCI), showing better cognitive performance and brain activity. The researchers propose a randomized controlled clinical trial examining the short (12 weeks) and long-term (12 months) efficacy of HBOT. The researchers will test hypotheses that HBOT compared to a sham condition improves cognitive function and increases cerebral blood flow and glucose utilization in MCI patients with T2D. Such patients are at high dementia risk and enriched in cerebrovascular disease, and thus have high potential for benefitting from HBOT. Aim 1 examines the potential beneficial effects of HBOT on cognition (with a primary composite measure of executive functions and episodic memory, both affected by T2D). Aim 2 examines effects of HBOT on ischemic injury which will be measured by CBF at the level of capillaries in gray matter (by MRI arterial spin labeling), and in macrovessels (by a novel 4D Flow MRI technology developed by the researchers of this group). Aim 3 focuses on effects of HBOT on cerebral glucose utilization using [F18]FDG-PET. Finally, Aim 4 investigates mediation by the biomarkers, i.e. whether their inclusion in a mediation model will attenuate the effect of HBOT on cognition, suggesting them as underlying mechanisms. This study will be performed in Israel, where there is optimal infrastructure and expertise for all the study components at significantly lower costs. HBOT can be widely deployed in the US so if successful, this pilot study will provide the basis for a multi-center large-scale clinical trial for definitive evidence of its benefits to cognition in T2D patients at high dementia risk. Despite advances in the understanding of risk factors and the pathologic basis for dementia, treatments are of very limited effects. As the proportion of elderly increases, the accelerating prevalence of T2D and dementia amplifies this application's public health impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT intervention | Experimental | Device: HBOT interventionThe 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. |
| Sham intervention | Sham comparator | Device: HBOT intervention, Device: Sham interventionExcept 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.). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Diagnosis of T2D
- Diagnosis of MCI
- > the age of 65
- Hebrew fluency
- An informant
Key exclusion criteria (10 listed)
- Brain disease that affects cognition (e.g. Parkinson's disease, schizophrenia).
- Stroke
- Epilepsy
- Chest pathology incompatible with HBOT
- Inner ear disease
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 |
|---|---|---|
| HBOT interventionAlso: Hyperbaric oxygen therapyHBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure. HBOT intervention arm - 3 months of HBOT treatment, 9 months observation all participants receive HBOT treatment for 3 months at year 2 | Device | HBOT intervention, Sham intervention |
| Sham interventionSham was selected as the control condition rather than "usual care" to equate intervention groups with respect to other variables that could influence cognition and functional status, such as a new challenge (completing an activity program), peer socialization, and attention from staff. | Device | Sham intervention |
Primary outcome
Change in Global Cognition Score
Time frame: baseline, 12, weeks, 6 months and 12 months
This analysis involves 11 cognitive performance variables, each measuring a specific aspect of cognition. In general, higher scores indicate better performance (Digit Symbol measures processing speed, Semantic Fluency measures verbal fluency, Word Recall Task measures immediate verbal memory, Delayed Word Recall Test measures delayed verbal memory, and Recall Unit measures immediate and delayed story recall), except for two variables (Trail Making Test Part A measures processing speed, Trail Making Test Part B measures cognitive flexibility) that measure time (where higher values indicate worse performance). These variables are standardized using Z-scores, which allow for combining and comparing values across different scales. The standardized values (Z-scores) of all 11 measures are averaged to create the composite score. Full range of composite score is -1 to 1. Higher composite Z-score reflects better cognitive performance and more favorable outcomes.
Cerebral Blood Flow
Time frame: baseline, 3 months, and 12 months
Cerebral blood flow (CBF) via arterial spin labeling magnetic resonance imaging (ASL-MRI). CBF is defined as the blood volume that flows per unit mass per unit time in brain tissue.
Whole Brain SUVr (FDG-PET)
Time frame: Baseline, 12 weeks, 12 months
Measures how actively the brain uses glucose, highlighting areas with abnormal activity that may signal diseases like Alzheimer's. Dimmer areas suggest reduced activity seen in disorders like dementia.
6 secondary outcomes
NIH Computerized Cognitive Test
Time frame: Baseline, 12 weeks, 6 months, 12 months
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time frame: baseline, 12, weeks, 6 months and 12 months
Beck Depression Inventory (BDI)
Time frame: baseline, 12 weeks, 6 months and 12 months
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI)
Time frame: baseline, 12 weeks, 6 months, and 12 months
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI)
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Total Mini-Mental State Examination (MMSE)
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified MRI and PET scans and cognitive scores will be made available for investigative collaborations. We expect to share these data with a large number of investigators throughout the world.
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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.
Michal Schnaider-Beeri, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Mary Sano, PhD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBOT intervention in people with Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai at 4 sites in 2 countries.
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 10 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Global Cognition Score (time frame: baseline, 12, weeks, 6 months and 12 months). The study lists 3 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 11 Aug 2025.