Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments

NCT04358796 | Completed

• 1 other identifier: 0031-17-ASF
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study was to examine the effect of short-term HBOT (hyperbaric oxygen treatments) on a range of cognitive abilities. The current study examined whether there is a HBOT-related short-term cognitive improvement and, if so, what specific cognitive abilities are improved by the intervention. Participants were randomized to perform cognitive tasks in one of two chambers with two different clinical environments: (a) HBOT condition: (2 ATA (atmosphere absolute) 100% oxygen for 90 minutes). (b) Control condition: in which the chamber was not pressurized (Normobaric condition- 1 ATA for 90 minutes).

Conditions

Hyperbaric Oxygen Therapy

Keywords

Cognitive enhancement; Memory; Information processing speed; Hyperbaric oxygen treatments

Outcome Measures

Primary Outcomes (6)

• memory

  Number of words retrieved from a list

  after 20 minutes of intervention

• Working memory

  accuracy rates on a working memory paradigm (n-back)

  after 20 minutes of intervention

• Divided attention

  accuracy rates on a divided attention task (identifying visual and auditory targets)

  after 20 minutes of intervention

• Information processing speed

  Accuracy rates on an information processing speed task (Symbol tracing task)

  after 20 minutes of intervention

• Response inhibition

  Accuracy rates on a response inhibition task (stroop)

  after 20 minutes of intervention

• Problem solving

  accuracy rates on a problem solving task (solving arithmetic series)

  after 20 minutes of intervention

Study Arms (2)

HBOT environment

EXPERIMENTAL

Cognitive testing in 2ATA, 100% oxygen in breathing-masks

Device: Hyperbaric oxygent treatment

Control environment

SHAM COMPARATOR

Cognitive testing in 1ATA, air in breathing-masks

Device: Control hyperbaric oxygen treatment

Interventions

Hyperbaric oxygent treatment DEVICE

Subjects will enter the oxygen chamber. ATA will be elevated to 2 ATA. They will breath 100% oxygen while solving cognitive tests designed to assess their cognitive capacities

HBOT environment

Control hyperbaric oxygen treatment DEVICE

Subjects will enter the oxygen chamber. ATA will be elevated to 1.2 ATA for a short while and the decreased back to 1 ATA. They will breath air while solving cognitive tests designed to assess their cognitive capacities

Control environment

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-40
• intact sight / corrected sight
• Hebrew as mother tongue
• Intact comprehension

You may not qualify if:

• Active neurologic or psychiatric diagnosis.
• Chest pathology ;
• Inner ear disease;
• Claustrophobia;

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, Israel

Location

Study Officials

• Shay Efrati

  Assaf-Harofeh Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are unaware to the ATA in chamber and to oxygen levels in their mask.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the Sagol Center for Hyperbaric Medicine

Model Details: two groups being tested in parallel. The first group in HBOT environment. The second group in a SHAM environment.

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: April 24, 2020
• Study Start: November 10, 2017
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)