Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2015-01-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
One hundred participants will receive home treatment with oxygen-enriched air (40% O2) through a nasal tube during the night (7 hours) for one month.
oxygen-enriched air -Normobaric hyperoxia treatment for depression
Forty percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours a day, throughout the night.
Placebo
100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month
oxygen-enriched air -Normobaric hyperoxia treatment for depression
Forty percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours a day, throughout the night.
Interventions
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oxygen-enriched air -Normobaric hyperoxia treatment for depression
Forty percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours a day, throughout the night.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* An unstable mental (psychiatric) condition
* A psychiatric condition that requires a change in pharmacotherapy (importantly - medications will not be changed in patients who will be enrolled to the study)
* Acute or chronic respiratory disease
* Any severe physical illness
* Suicidal thoughts or attempts
* Drug abuse
* Obesity (BMI over 30)
* Inability to cease smoking during night hours while participants are supposed to be using the oxygen/air supplementing machine.
18 Years
65 Years
ALL
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Locations
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Clalit Health Services in the Southern region
Beersheba, , Israel
Countries
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Facility Contacts
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Pesach Shvartzman, M.D.
Role: primary
References
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Bloch Y, Belmaker RH, Shvartzman P, Romem P, Bolotin A, Bersudsky Y, Azab AN. Normobaric oxygen treatment for mild-to-moderate depression: a randomized, double-blind, proof-of-concept trial. Sci Rep. 2021 Sep 23;11(1):18911. doi: 10.1038/s41598-021-98245-9.
Other Identifiers
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002
Identifier Type: -
Identifier Source: org_study_id
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