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NCT03036254 · ClinicalTrials.gov registry record · NA
Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk
A NA study of Diabetes Mellitus, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 155
- Enrollment target
- 4
- Study locations
NCT03036254: Completed NA study of Diabetes Mellitus, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03036254 is a NA study of Diabetes Mellitus that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 155 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03036254, a NA study of Diabetes Mellitus, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 155 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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 Mak
Conditions Studied
Interventions
- DEVICE Sham intervention
- DEVICE HBOT intervention
Study Locations (4)
Other
- Sheba Medical Center - Ramat Gan
- Assaf HaRofeh Medical Center - Tzrifin
New York
- Icahn School of Medicine at Mount Sinai - New York
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2017-08-10 |
| Est. Completion | 2024-04-15 |
| Phase | NA |
What the finished NCT03036254 record still lists
NCT03036254 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Sham intervention is the first listed.
NCT03036254 reports a single indexed study location in Other, New York, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03036254 about?
NCT03036254 is a clinical study titled "Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk". 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,...
What is the current status of trial NCT03036254?
This trial is currently completed. It is a NA study. The enrollment target is 155 participants. The study started on 2017-08-10. Estimated completion is 2024-04-15.
What conditions does trial NCT03036254 study?
This clinical trial studies the following conditions: Diabetes Mellitus.
What interventions are being tested in trial NCT03036254?
The interventions under investigation include: Sham intervention (DEVICE), HBOT intervention (DEVICE).
Who is sponsoring clinical trial NCT03036254?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03036254 being conducted?
This trial has 4 study locations across New York, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03036254's enrollment target sits among peer trials
155 99th of 208 higher than 110 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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