Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

NCT07423273 | Recruiting DMC

• 1 other identifier: 0202-23
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.

Conditions

Post Stroke Depression

Keywords

hyperbaric oxygen therapy

Outcome Measures

Primary Outcomes (1)

• PSD symptoms

  Depression severity will be evaluated by structured interview based on the HDRS-17 guided structural questioner (Hamilton Depression Rating Scale from 0-53 ,Levels of depression is categorized according to the following accepted criteria: * Not depressed: 0-7 * Mild (subthreshold): 8-13 * Moderate: 14-18 * Severe: 19-22 * Very severe: \>23)

  Change from Baseline immediately after the intervention

Secondary Outcomes (24)

• depression

  Change from Baseline immediately after the intervention

• Short form health survey (sf-36)

  at baseline, 3 months, 6 months

• psychological distress

  Change from Baseline immediately after the intervention

• health status

  Change from Baseline immediately after the intervention

• independent living skills

  Change from Baseline immediately after the intervention

Study Arms (2)

hyperbaric oxygen therapy (HBOT) active treatment

ACTIVE COMPARATOR

The HBOT protocol consists of 60 daily sessions, five times per week, within a three months' period. Then there will be a follow-up period for 3 months without any investigated intervention. each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes.

Device: hyperbaric oxygen therapy

Sham hyperbaric oxygen therapy (HBOT) Sham treatment

SHAM COMPARATOR

All the conditions provided in the HBOT intervention will be provided in the sham intervention. However, in contrast to the HBOT, each session includes breathing 21% oxygen by mask while in the same multiplace chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks, every 20 minutes The initial 1.2 ATA level will provide a minimal pressure sensation in the ears, with the same nurse advice on pumping the ears. In the last five minutes of the session, the air will be circulated again with its related noises. Sham and HBOT sessions will never be adjacent, so subjects from the two groups cannot meet and discuss the session and its effects.

Device: hyperbaric oxygen therapy

Interventions

hyperbaric oxygen therapy DEVICE

The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel.

Sham hyperbaric oxygen therapy (HBOT) Sham treatment; hyperbaric oxygen therapy (HBOT) active treatment

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 -85
• Treated or being treated by antidepressants for at least 3 months
• Diagnosis of PSD based on HDRS-17 score of 17 and above.
• Subject willing and able to read, understand and sign an informed consent.

You may not qualify if:

• Inability to attend scheduled clinic visits and/or comply with the study protocol
• Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.
• Diagnosis of aphasia or major cognitive decline
• History of Deep brain stimulation (DBS)
• History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
• Active malignancy
• Substance use at baseline.
• History of other neurodegenerative diseases including Alzheimer's disease (AD), Parkinson's disease (PD), Lewy body dementia (LBD), Frontotemporal dementia (FTD), Multiple sclerosis (MS), Amyotrophic lateral sclerosis (ALS), Creutzfeld Jacob disease (CJD), Multisystem atrophy (MSA), Pseudobulbar palsy (PSP), Corticobasal degeneration (CBD), Wernicke Korsakoff syndrome
• Serious suicidal ideation
• Renal or liver insufficiency, electrolyte imbalances
• Chronic heart failure with ejection fraction of 30 or less
• HBOT for any reason prior to study enrolment
• Chest pathology incompatible with pressure changes (including active asthma or COPD)
• Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
• An inability to perform an awake brain MRI

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Shai a Efrati, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai a Efrati, MD

CONTACT

972549212866; efratishai@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: February 20, 2026
• Study Start: November 8, 2023
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

IL (1)