Air Purifier to Improve Endothelial Function and Carotid Intima Thickness

Cognitive Impairment Clinical Trial

Official title:

A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301402
• Other study ID #: 2017.304
• Status: Completed
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: January 5, 2021

Study information

• Verified date: May 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: There is epidemiological evidence or link ambient air pollution exposure to the incidence of dementia.

Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air purification improves endothelial function and carotid intima thickness in older diabetic people with cognitive impairment.

Subjects and method: People with clinically diagnosis mild cognitive impairment or early dementia will be recruited. After obtaining written consent, the subjects will be assessed cognitive function and arterial health. After baseline measurements, the subjects are randomly assigned to have either filter or no filter installed in the air purifier. The air purifier will be placed in living room of the household of the subject for one year. At one year, the measurements will be repeated.

Statistical analysis: Intention to treat analysis will be adopted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Diabetic people

• Mild cognitive impairment or early dementia

Exclusion Criteria:

• Current smoker

• The presence of a smoker in the household

• The absence of a reliable family caregiver

• The lack of mental capacity to give informed consent

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Endothelial Function

Intervention

Device:
• Air purifier
Air purifier with filter at automatic mode on all time

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMD%	Endothelial function will be assessed by Flow mediated dilatation of brachial artery	12 months