A Neuroimaging Study to Evaluate the Effects and Efficacy Mechanism of Oxygen Therapy on subjective cognitive impairment
- Conditions
- Not Applicable
- Registration Number
- KCT0004341
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Those who complain subjective cognitive impairment (SCI) between the ages of 19 and 65
- A history of mild traumatic brain injury
- Those who voluntarily agree to participate in the study and can visit for the next observation
- Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests
- Having neurological abnormalities or any disorders that may affect brain MR imaging (e.g. history of penetrating or open head injury, epilepsy, multiple sclerosis, brain tumor, or cerebrovascular disorder)
- Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding
- Had taken psychotropic drugs within the past 2 months before study participation
- Participated in another clinical trial within the past 1 months before screening
- Any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in the body)
- A history of pneumothorax
- A history of ear-related diseases (i.e., otitis media, eardrum-related diseases)
- Inappropriate to participate in this study by principal investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in brain metabolite concentration and perfusion assessed by magnetic resonance imaging data;Change of attention, memory, executive functions and etc. assessed by the neuropsychological test battery;Change in the depressive symptom levels assessed by the Beck Depression Inventory;Change in the anxiety symptom levels assessed by the Beck Anxiety Inventory
- Secondary Outcome Measures
Name Time Method Change in sleep and fatigue (PSQI, FSS);Change in quality of life (MOS-SF36);Change in subjective memory function (SMCQ);Change in emotional status (K-POMS)