Oxygen Therapy in Depression

Clalit Health Services

Status: Unknown

Conditions: Depression, Normobaric Hyperoxia.

Treatments: Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression

Study type: Interventional

Funder types: Other

Identifiers

NCT02149563

002

Details and patient eligibility

About

The major objective of the present study is to examine the influence of normobaric hyperoxia treatment on the symptoms of patients diagnosed with depression members of Clalit Health Services. The investigators hypothesize that normobaric hyperoxia treatment will improve the symptoms of patients with depression.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged 18-65 years diagnosed with mild to moderate depression.

Exclusion criteria

• Patients with oxygen saturation below 95%;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

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.

Treatment:

Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression

Placebo

Placebo Comparator group

Description:

100 participants will receive regular air treatment (21% O2) through a nasal tube (identical to the procedure providing 40% O2) for one month

Treatment:

Device: oxygen-enriched air -Normobaric hyperoxia treatment for depression