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Recruiting

NCT Number: NCT05953233

School Inner City Air Study

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?

Recruiting

Interested in participating?

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Key information

Age range

6 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Peggy Lai, MD MPH

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children

  • Grades K-5 (age 6-12 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 and also willing to participate in the study

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

Treatment and study plan

Active classroom HEPA cleaner

Other

Commercially available portable HEPA cleaner

Sham classroom HEPA cleaner

Other

Commercially available portable HEPA cleaner with filtration device removed

Primary outcomes

  1. Viral pathogen detected in upper respiratory sample

    Time frame: 1 year

    Presence/absence of a respiratory virus in upper respiratory sample

Secondary outcomes

  1. Symptomatic respiratory infection (student, teacher)

    Time frame: 1 year

    Presence/absence of a cold based on 30 day recall

  2. Symptomatic respiratory infection (household member)

    Time frame: 1 year

    Presence/absence of a cold based on 30 day recall

  3. Viral detection in classroom bioaerosol sample

    Time frame: 1 year

    Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)

  4. Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report

    Time frame: 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.

  5. Severity of a cold in adult using the WURSS-24

    Time frame: 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.

  6. Number of missed school or work days in last 30 days

    Time frame: 1 year

    30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe.

  7. Number of days requiring inpatient or outpatient care in last 30 days

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peggy Lai, MD MPH

CONTACT

[email protected]

617-875-9878

Wanda Phipatanakul, MD MS

CONTACT

[email protected]

857-218-5336

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston Children's Hospital
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Jul 20, 2023
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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