NCT05172388

Brief Summary

This study aims to explore the cardiopulmonary health effects of indoor air purification and other indoor environmental conditions among young healthy college students in Beijing, China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 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

First Submitted

Initial submission to the registry

November 30, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 29, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

November 30, 2021

Last Update Submit

October 10, 2022

Conditions

Cardiopulmonary Diseases

Outcome Measures

Primary Outcomes (3)

  • Changes in heart rate variability

    Including the standard deviation of all normal-to-normal R-R intervals (SDNN) in millisecond, standard deviation of sequential five-minute R-R interval means (SDANN) in millisecond, root-mean-square difference of successive normal R-R intervals (rMSSD) in millisecond, low frequency (LF) in squared millisecond, and high frequency (HF) in squared millisecond.

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

  • Changes in blood pressure

    Including the systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, and pulse pressure (PP) in mmHg.

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

  • Changes in pulmonary function

    Including forced expiratory volume in 1 s (FEV1) in liter, forced vital capacity (FVC) in liter, forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio, and peak expiratory flow (PEF) in liter per second.

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

Secondary Outcomes (14)

  • Changes in levels of airway inflammation

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

  • Changes in levels of C-reactive protein (CRP)

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

  • Changes in levels of 8-hydroxydeoxyguanosine (8-OHdG)

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

  • Changes in levels of sleep-related parameters

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

  • Changes in levels of sleep-breathing parameters

    Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)

  • +9 more secondary outcomes

Study Arms (2)

Real purification

ACTIVE COMPARATOR

Air purifier turned on.

Other: Air purifier

Sham purification

SHAM COMPARATOR

Air purifier turned off.

Other: Air purifier

Interventions

Air purifierOTHER

Real purification and sham purification would be conducted in the dormintory rooms (about 25 in total) of the study subjects for 4 days, following a randomized crossover design, which means a real air purifier and a sham purifier would be placed in the same dormintory room with a wash-out interval (15 days).

Real purificationSham purification

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Living in Beijing for more than one consecutive years;
  • College students between 18-28 years;

You may not qualify if:

  • Current or past smokers;
  • Body mass index (BMI) over 28.0 kg/m2.
  • Alcohol addict;
  • Having thoracic surgery history;
  • History of diagnosed chronic disease;
  • Hepatitis B / hepatitis C virus patient / carrier;
  • Unwilling or unable to provide informed consent or cooperate with all research related procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, 100191, China

Location

MeSH Terms

Conditions

Pulmonary Heart Disease

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD & PhD, Professor, Deputy Director Department of Occupational & Environmental Health Sciences

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 29, 2021

Study Start

December 29, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

CN(1)