NCT03301402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

3.3 years

First QC Date

September 28, 2017

Last Update Submit

May 28, 2021

Conditions

Endothelial FunctionCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • FMD%

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

    12 months

Study Arms (2)

Filter

ACTIVE COMPARATOR
Device: Air purifier

No filter

NO INTERVENTION

Interventions

Air purifierDEVICE

Air purifier with filter at automatic mode on all time

Filter

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diabetic people
  • Mild cognitive impairment or early dementia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Study Officials

  • Timothy Kwok

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 4, 2017

Study Start

September 22, 2017

Primary Completion

January 5, 2021

Study Completion

January 5, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations

HK(1)