A Neuroimaging Study to Evaluate the Effects and Efficacy Mechanism of Oxygen Therapy on subjective cognitive impairment

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004341

Enrollment

Registered

2019-10-17

Start date

2018-10-15

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Oxygen therapy) : Oxygen therapy group will be treated with 20 sessions of Hyperbaric oxygen therapy (HBOT) each consisting of 65 minutes at or below 1.5 atmospheres absolute. No-intervention g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactJungyoon Kim

Ewha Womans University

jungyoon.kimm@gmail.com+82-2-3277-6555

Outcome results