Endothelial FunctionNCT03301402
Air Purifier to Improve Endothelial Function and Carotid Intima Thickness
A study testing Air purifier in people with Endothelial Function and Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Endothelial Function, Cognitive Impairment
- What is being tested?
- Air purifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Sep 2017to 5 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diabetic people
- Mild cognitive impairment or early dementia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment
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.
Read more
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
- Being tested
- Air purifier
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purifierDevice
Air purifier with filter at automatic mode on all time
| Study group | Role | What they receive |
|---|---|---|
| Filter | Active comparator | Not described Receives: Device: Air purifier |
| No filter | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMD%
Endothelial function will be assessed by Flow mediated dilatation of brachial artery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start22 Sep 2017
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
- Investigators
- Timothy Kwok, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301402
- Sponsor's protocol ID
- 2017.304
- Status last verified
- May 2021
- First submitted
- 28 Sep 2017
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03301402
- Acronym / sponsor ID
- 2017.304
- Conditions
- Endothelial Function, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filter | Active comparator | Device: Air purifier |
| No filter | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Diabetic people
- Mild cognitive impairment or early dementia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air purifierAir purifier with filter at automatic mode on all time | Device | Filter |
Primary outcome
FMD%
Time frame: 12 months
Endothelial function will be assessed by Flow mediated dilatation of brachial artery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Kwok principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air purifier in people with Endothelial Function and Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMD% (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.