N/A
N=155
Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03036254 ↗Enrolled (actual)
155
Serious AEs
15.5%
Results posted
Aug 2025
Primary outcome: Primary: Change in Global Cognition Score — -0.012; 0.021; 0.18; 0.32 Composite z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HBOT intervention (Device); Sham intervention (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Cognition Score |
-0.012; 0.021; 0.18; 0.32; 0.38; 0.48 | — |
| PRIMARY Cerebral Blood Flow |
219.39; 207.86; 227.68; 227.64; 216.91; 216.91 | — |
| PRIMARY Whole Brain SUVr (FDG-PET) |
0.009; -0.022; -0.128; 0.379; -0.266; -0.0004 | — |
| SECONDARY NIH Computerized Cognitive Test |
— | — |
| SECONDARY Clinical Dementia Rating-Sum of Boxes (CDR-SB) |
1.60; 1.51; 0.75; 0.67; 0.61; 0.76 | — |
| SECONDARY Beck Depression Inventory (BDI) |
5.43; 5.31; 5.57; 4.74; 6.62; 4.88 | — |
| SECONDARY Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI) |
24.34; 24.60; 25.43; 25.58; 25.71; 25.84 | — |
| SECONDARY Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI) |
45.24; 44.71; 47.5; 48.41; 47.69; 47.29 | — |
| SECONDARY Total Mini-Mental State Examination (MMSE) |
28.56; 28.49; 28.26; 28.38; 28.04; 28.53 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of T2D
- Diagnosis of MCI
- > the age of 65
- Hebrew fluency
- An informant
Exclusion Criteria
- Brain disease that affects cognition (e.g. Parkinson's disease, schizophrenia).
- Stroke
- Epilepsy
- Chest pathology incompatible with HBOT
- Inner ear disease
- Claustrophobia
- 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
Data sourced from ClinicalTrials.gov (NCT03036254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.