Planned study of hyperbaric oxygen therapy versus sham for mild cognitive dysfunction in elderly patients with diabetes.

Clinical bottom line:

1. Trial protocol only - no results to date

Citation/s:1. BenAri, Efrati S, Hadanny A, Sano M, Bendlin BB, Lin H, Liu X, Sela I, Almog G, Livny A, Sandler I, Ben-Haim S. A double-blind placebo-controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design. Alzheimer's & Dementia: Translational Research & Clinical Interventions. 2020;6(1):e12008.
Lead author's name and fax: Ori BenAri. Correspondent: Michal Beeri:

Three-part Clinical Question:For elderly patients with Type-II diabetes mellitus and mild cognitive impairment (MCI), does a course of hyperbaric oxygen result in improvement in cognition, cerebral bloodflow or glucose uptake?
Search Terms: Diabetes mellitus; cognitive impairment; vascular neogenesis

The Study:Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: 154 elderly Israeli patients with Type-II DM and demonstrated MCI with MMSE >24 and Clinical Dementia Rating of 0.5.
Control group (N = 77): Patients breathing air at 1 ATA in a hyperbaric chamber for 90 minutes with a short excursion to 1.1 ATA at the start and end of the treatment period. Total of 60 sessions for five days each week.
Experimental group (N = 77): As above but breathing 100% oxygen at 2 ATA..

The Evidence:None at writing

1. Well-designed trial with sham therapy and comprehensive outcomes. It is not clear if the authors intend to test the success of blinding. No definition given of ‘elderly’.
2. The interesting definition of HBOT as using 'oxygen enriched air' is not standard.
3. Outcomes included aim at the impact on neuronal functioning, CBF and glucose utilization.
4. Authors do not remark on the well-described effect of HBO exposure on blood sugar as being of potential relevance.

Appraised by: Mike Bennett; Monday, 1 February 2021

Kill or Update By: February 2023