Air Purifier to Improve Endothelial Function and Carotid Intima Thickness

NCT ID: NCT03301402

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-22
• Study Completion Date: 2021-01-05

Brief 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.

Conditions

Endothelial Function; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Filter

Group Type: ACTIVE_COMPARATOR

Air purifier

Intervention Type: DEVICE

Air purifier with filter at automatic mode on all time

No filter

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Air purifier

Air purifier with filter at automatic mode on all time

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Timothy Kwok

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Kwok

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

2017.304

Identifier Type: -

Identifier Source: org_study_id