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Air Purifier to Improve Endothelial Function and Carotid Intima Thickness

Primary Purpose

Endothelial Function, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Air purifier
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endothelial Function

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Filter

No filter

Arm Description

Outcomes

Primary Outcome Measures

FMD%
Endothelial function will be assessed by Flow mediated dilatation of brachial artery

Secondary Outcome Measures

Full Information

First Posted
September 28, 2017
Last Updated
May 28, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03301402
Brief Title
Air Purifier to Improve Endothelial Function and Carotid Intima Thickness
Official Title
A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Function, Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filter
Arm Type
Active Comparator
Arm Title
No filter
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Air purifier
Intervention Description
Air purifier with filter at automatic mode on all time
Primary Outcome Measure Information:
Title
FMD%
Description
Endothelial function will be assessed by Flow mediated dilatation of brachial artery
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Kwok
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Air Purifier to Improve Endothelial Function and Carotid Intima Thickness

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