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Effect and safety of hyperbaric oxygen on mild cognitive impairment in elderly patients with cerebral small vascular disease: a prospective, single blind, randomized, controlled trial

Effect and safety of hyperbaric oxygen on mild cognitive impairment in elderly patients with cerebral small vascular disease: a prospective, single blind, randomized, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015788
Enrollment
Unknown
Registered
2018-04-20
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Cerebral small vascular disease

Interventions

Goup 1:hyperbaric oxygen

Sponsors

Navy General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male and non pregnant, non lactating women, 60 years old and over 60 years old, have higher education level; 2. Head MRI imaging T2WI and FLAIR images have the following manifestations: leukoaraiosis, lacunar cerebral infarction, cortical and watershed infarcts, and subcortical lesions with a diameter of 15 mm; 3. There is cognitive impairment in the report of the main or the insider; 4. The clinical dementia rating scale (CDR) score was normal, the MMSE score was 21-26, the total MoCA score was less than 26 (corrected according to the degree of cultural bias, the year of education was less than or equal to 12 years, plus 1), and the ADL score was normal or mild (14-22); 5. Inspection cooperation; 6. The informed consent is signed by the patient himself or the legal guardian.

Exclusion criteria

Exclusion criteria: 1. White matter lesions are caused by definite etiologies, such as inflammation, tumor and poisoning; 2. Cortical or cortical / subcortical mixed lesions, subcortical non lacunar infarcts, hemorrhagic lesions; 3. There are definite other causes of cognitive impairment, such as Alzheimer's disease (AD), Parkinson's disease and normal intracranial pressure hydrocephalus; 4. Ethanol or drugs addicts; 5. Patients with severe heart, liver, kidney, hematopoietic system and thyroid diseases; 6. Patients who used folic acid, vitamin B6 and vitamin B12 for 2 weeks were taken to improve cognition, antidepressants and antipsychotics; 7. People with visual impairment and hearing impairment who have significant influence on cognitive tests; 8. Contraindications include hyperbaric oxygen therapy, such as pneumothorax, Eustachian tube pressure regulation, and internal bleeding.

Design outcomes

Primary

MeasureTime frame
effect;

Secondary

MeasureTime frame
Cerebral oxygen supply;Cerebral microcirculation;MRS;DTI;

Countries

China

Contacts

Public ContactDazhi Guo

Department of Hyperbaric Oxygen, Navy General Hospital

guodazhigod1983@163.com+86 18600317342

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026