NCT03126669

Brief Summary

The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enable better performance of complex and/or multiple activities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
Last Updated

April 21, 2026

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

April 20, 2017

Last Update Submit

April 16, 2026

Conditions

Keywords

Hyperbaric oxygenmultitasking performancecognitive funcitons

Outcome Measures

Primary Outcomes (2)

  • Cognitive/Attention Symbol-Digit Modality Test (SDMT)

    Three different forms of the SDMT were used in each evaluation session. The first was a try-out for the test, ensuring understanding of the task. The second tests the ability to per-form an individual task. The third form was used together with the motor test for examin-ing dual task performance. Standard administration procedures were followed as indicat-ed in the test manual. The score of the test is the number of correct substitutions during 90-second interval.

    45 minutes

  • Motor task: transferring of beans

    Motor performance was evaluated by the Motor Assessment Scale test (MAS) - transfer-ring units of beans one by one between two tea cups an arm length away.

    45 minutes

Study Arms (2)

Treratment

ACTIVE COMPARATOR

100% oxygen at 2 ATA at the hyperbaric chamber

Device: Hyperbaric oxygen

Placebo

PLACEBO COMPARATOR

normal air, in the hyperbaric chamber

Device: Hyperbaric chamber, normal air

Interventions

Breathing 100% oxygen at 2ATA in the hyperbaric chamber

Treratment

Hyperbaric chamber with normal air

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers,
  • minimum of 12 years of formal education

You may not qualify if:

  • any inner ear pathologies,
  • any lung disease,
  • any mental or physical limitation of participat in going into oxygen chamber environment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Shai a Efrati, MD

    Asaf-Harofhe MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 24, 2017

Study Start

November 1, 2014

Primary Completion

November 30, 2016

Study Completion

March 25, 2017

Last Updated

April 21, 2026

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations