Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:
• Age between 50 -85
• Suffered an ischemic stroke 6 months to 7 years prior to their inclusion
• Treated or being treated by antidepressants for at least 3 months
• Diagnosis of PSD based on HDRS-17 score of 17 and above.
• Stable psychological and pharmacological treatment for more than three months prior to inclusion.
• Subject willing and able to read, understand and sign an informed consent.
Locations
Other Locations
Israel
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
RECRUITING
Zrifin
Contact Information
Primary
Shai a Efrati, MD
efratishai@outlook.com
972549212866
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 142
Treatments
Active_comparator: hyperbaric oxygen therapy (HBOT) active treatment
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.
Sham_comparator: Sham hyperbaric oxygen therapy (HBOT) Sham treatment
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.
Related Therapeutic Areas
Sponsors
Leads: Assaf-Harofeh Medical Center