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

NCT03036254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2025-08-11

Study results available
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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

Interventions

DEVICE

HBOT intervention

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

DEVICE

Sham intervention

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.

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Assaf-Harofeh Medical Center

    collaborator OTHER_GOV

  • University of Wisconsin, Madison

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Michal Schnaider-Beeri, PhD · Icahn School of Medicine at Mount Sinai

  • Mary Sano, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2024-04-15
Completion
2024-04-15
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03036254 on ClinicalTrials.gov