Depression, Normobaric Hyperoxia.
Conditions
Brief summary
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.
Interventions
DEVICEoxygen-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.
Sponsors
Meir Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression (HRSD)-changes in patients' depression. | Baseline (time zero), 2 weeks and 4 weeks | HRSD will be used to assess changes in patients' condition. Assessment will be performed at 3 time points: baseline (time zero), 2 weeks and 4 weeks after treatment initiation, by a trained psychiatric nurse blind to the patient's treatment status. |
Countries
Israel
Outcome results
None listed