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

NCT03036254 | Completed Results FDA Device

• 1 other identifier: GCO 15-0192
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Cognition

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 12 weeks, 12 months

Secondary Outcomes (6)

• NIH Computerized Cognitive Test

  Baseline, 12 weeks, 6 months, 12 months

• Clinical Dementia Rating-Sum of Boxes (CDR-SB)

  baseline, 12, weeks, 6 months and 12 months

• Beck Depression Inventory (BDI)

  baseline, 12 weeks, 6 months and 12 months

• Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI)

  baseline, 12 weeks, 6 months, and 12 months

• Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI)

  Baseline, 12 weeks, 6 months, and 12 months

Study Arms (2)

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.

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.).

Device: HBOT intervention; Device: Sham intervention

Interventions

HBOT intervention DEVICE

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

Also known as: Hyperbaric oxygen therapy

HBOT intervention; Sham intervention

Sham intervention DEVICE

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.

Sham intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of T2D
• Diagnosis of MCI
• \> the age of 65
• Hebrew fluency
• An informant

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Sheba Medical Center: collaborator
• Assaf-Harofeh Medical Center: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (4)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Wisconsin

Madison, Wisconsin, 53076, United States

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Assaf HaRofeh Medical Center

Tzrifin, 70300, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Mary Sano
• Organization: Icahn School of Medicine at Mount Sinai

mary.sano@mssm.edu

(212) 659-8838

Study Officials

• Michal Schnaider-Beeri, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Mary Sano, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 30, 2017
• Study Start: August 10, 2017
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2); IL (2)