School Inner City Air Study

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05953233

Collaborator

Boston Children's Hospital (Other)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this randomized clinical trial is to test the efficacy of high efficiency particulate air (HEPA) cleaners in reducing respiratory viral exposure and infections in elementary school classrooms. Classrooms will be randomized to active vs. sham HEPA cleaners.

The main questions it aims to answer are:

Do classroom HEPA cleaners reduce exposure to viruses?
Do classroom HEPA cleaners reduce student and teacher infections?
Do classroom HEPA cleaners reduce infections in family members?

Condition or Disease	Intervention/Treatment	Phase
Viral Infection	Other: Active classroom HEPA cleaner Other: Sham classroom HEPA cleaner	N/A

Detailed Description

Classrooms from participating schools will be randomized to active vs. sham HEPA cleaners. From enrolled classrooms, we will enroll students, teachers, and members of the household. We will collect the following:

longitudinal classroom air samples
longitudinal upper respiratory samples
longitudinal symptom surveys using the Wisconsin Upper Respiratory Symptom Survey (WURSS) Viral testing on collected air and respiratory samples will be performed using digital polymerase chain reaction (dPCR).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA armsClassrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Sham cleaners are constructed by removing the filters from air cleaners and adding a sound generator rendering them indistinguishable from active HEPA cleaners.

Primary Purpose:

Prevention

Official Title:

School Inner City Air Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2029

Anticipated Study Completion Date :

Aug 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active HEPA cleaner Active HEPA cleaners will be placed in classrooms throughout the school year	Other: Active classroom HEPA cleaner Commercially available portable HEPA cleaner
Placebo Comparator: Sham HEPA cleaner Sham HEPA cleaners will be placed in classrooms throughout the school year	Other: Sham classroom HEPA cleaner Commercially available portable HEPA cleaner with filtration device removed

Arm

Intervention/Treatment

Experimental: Active HEPA cleaner

Active HEPA cleaners will be placed in classrooms throughout the school year

Other: Active classroom HEPA cleaner

Commercially available portable HEPA cleaner

Placebo Comparator: Sham HEPA cleaner

Sham HEPA cleaners will be placed in classrooms throughout the school year

Other: Sham classroom HEPA cleaner

Commercially available portable HEPA cleaner with filtration device removed

Outcome Measures

Primary Outcome Measures

Viral pathogen detected in upper respiratory sample [1 year]
Presence/absence of a respiratory virus in upper respiratory sample

Secondary Outcome Measures

Symptomatic respiratory infection (student, teacher) [1 year]
Presence/absence of a cold based on 30 day recall
Symptomatic respiratory infection (household member) [1 year]
Presence/absence of a cold based on 30 day recall
Viral detection in classroom bioaerosol sample [1 year]
Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)
Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report [1 year]
Severity of a cold (when present) in child will be graded using the Wisconsin Upper Respiratory Symptom Survey Kids Daily Symptom Report (WURSS-K). Range 0 - 42; higher indicates more severe.
Severity of a cold in adult using the WURSS-24 [1 year]
Severity of a cold (when present) in adult will be graded using the Wisconsin Upper Respiratory Symptom Survey 24 Daily Symptom Report (WURSS-24). Range 0 - 161; higher indicates more severe.
Number of missed school or work days in last 30 days [1 year]
30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe.
Number of days requiring inpatient or outpatient care in last 30 days [1 year]
30 day recall of healthcare utilization defined as number of days requiring outpatient or inpatient hospital care. Range 0 - 30; higher indicates more severe.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children

Grades K-8 (age 6-15 years)
Attend one of the schools that the study team has permission to obtain classroom/school environmental samples
Have no plans to move schools within the upcoming 12 months
Subject and/or parent guardian must be able to understand and provide informed consent

Adults

Adult (age 21 or older) parent, caretaker, or household member of child participating in this study, or teacher in classroom participating in study
Able to understand and provide informed consent

Exclusion Criteria:

Children

Contraindication to or inability to participate in home self-collection of nasal swab samples
Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures

Adults

Contraindication to or inability to participate in home self-collection of nasal swab samples
Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Massachusetts General Hospital
Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peggy S Lai, Associate Professor, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05953233

Other Study ID Numbers:

IRB-P00045373

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Virus Diseases

Study Results

No Results Posted as of Jul 20, 2023