NCT02790541

Brief Summary

Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis, increased tissue blood flow and oxygenation correlated with tissue function. Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned organs associated with aging-related malfunctions due to restored mitochondrial function, mobilization of stem cells and induction of angiogenesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

May 3, 2016

Last Update Submit

April 19, 2026

Conditions

Aging

Keywords

agingHBOTreverseangiogenesiselderlymitochohndria

Outcome Measures

Primary Outcomes (3)

  • Change from baseline of Angiogenesis in brain MRI at 3 and 6 months

    imaging will be performed for evaluation of brain changes and angiogenesis processs using MRI perfusion (DSC)

    at baseline, 3 and 6 months

  • Change from baseline of general cognitive functions index at 3 and 6 months

    Patients' cognitive functions will be assessed by Neurotrax computerized cognitive tests to generate the general cognitive index

    at baseline, 3 and 6 months

  • Change from baseline of exercise VO2 MAX at 3 and 6 months

    Using a standard exercise test which includes gas analysis, the change in VO2 maxs will be assessed 3 and 6 months compared to baseline

    at baseline, 3 and 6 months

Secondary Outcomes (5)

  • Change in number of circulating stem cells (CD34) at 3 and 6 months

    at baseline, 3 and 6 months

  • Change from baseline of proteinuria at 3 and 6 months

    at baseline, 3 and 6 months

  • Change from baseline of Methacetin breath test at 3 and 6 months

    at baseline, 3 and 6 months

  • Change from baseline in bone density at 3 and 6 months

    at baseline, 3 and 6 months

  • Change from baseline in quality of life measured by SF-36 form at 3 and 6 months

    at baseline, 3 and 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Hyperbaric Oxygen Therapy: 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week

Device: Hyperbaric Oxygen Therapy

Control/Crossover

OTHER

Hyperbaric Oxygen Therapy: 3 months control period (no treatment) followed by 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week

Device: Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen TherapyDEVICE

60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.

Also known as: HBOT
Control/CrossoverTreatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age≥ 65 years
  • Capability to sign informed consent.

You may not qualify if:

  • Severe cognitive decline (MMSA\<17)
  • Severe chronic renal failure (GFR \<30)
  • Uncontrolled diabetes mellitus (HbA1C\>8, fasting glucose\>200)
  • Immunosuppressant from any reason
  • Contraindications to perform MRI: claustrophobia, allergy to gadolinium, foreign bodies, pacemaker, etc.
  • Active Smoking.
  • Pulmonary diseases such as severe emphysema, moderate-severe obstructive disease.
  • Medical conditions deemed by the investigator to make the patient ineligible for protocol investigations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (1)

  • Hadanny A, Sasson E, Copel L, Daniel-Kotovsky M, Yaakobi E, Lang E, Fishlev G, Polak N, Friedman M, Doenyas K, Finci S, Zemel Y, Bechor Y, Efrati S. Physical enhancement of older adults using hyperbaric oxygen: a randomized controlled trial. BMC Geriatr. 2024 Jul 3;24(1):572. doi: 10.1186/s12877-024-05146-3.

    PMID: 38961397DERIVED

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 3, 2016

First Posted

June 6, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)