Indoor Air Quality Asthma Study: The Effect of Indoor Air Quality and Mitigation of Same on Persistent Asthma

NCT ID: NCT05843045

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2026-01-12

Brief Summary

The primary objective is to determine whether continuous sensing, control and mitigation of home indoor air quality influences the frequency of asthma related symptoms, as measured by Serum IgE, Spirometry with exhaled Nitric Oxide, missed school and workdays, need for pharmacologic intervention (albuterol, oral steroids), frequency of sick visits to pulmonologist or primary care provider (PCP), urgent care / emergency department visits, and hospitalizations

Detailed Description

Participants will be in the research study for approximately 2 years. There will be 11 visits to the clinic for monitoring of asthma symptoms and pulmonary function and 16 interval contacts with research staff made by either telephone or email to monitor asthma symptoms. There will also be 5 visits to participants' homes by technicians from Emerson Climate Technologies and/or an electrician in cooperation with Emerson. During these visits Emerson employees will assess participants' homes to determine if they qualify for the study and install study equipment to monitor air quality for the first half of the study and monitor and mitigate air quality for the second half of the study. At the end of the study, the technicians and/or electrician from Emerson will reset the study equipment or replace participants' original equipment, if that is their wish.

Participants will be enrolled in the research study for approximately 2 years. The first year, technicians from the study sponsor will install indoor air quality monitoring equipment in the participants' homes and information about the air quality in their home as well as baseline health and asthma information will be collected. This will be done through continuous sensing via an Atmocube air quality sensor, and a portable air quality sensor, the Atmotube. Beginning in the second half of the study, mitigation strategies of a smart home thermostat, the Sensi Touch Smart Thermostat, a smart bath fan control, the Enbrighten Z-wave Switch, and high quality furnace filter, 3M Filtrete MPR 2800 Ultrafine Particle Reduction Air Filter, will be employed. Information about the participants' asthma, health status, and air quality in the homes will continue to be collected.

Conditions

Persistent Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pre-mitigation

Information will be collected from participants about their health status and asthma symptoms. Information about the air quality inside the participants' homes will also be collected.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Indoor Air Quality Mitigation

Indoor air quality mitigation strategies of a smart home thermostat, smart bath fan switch, and a high-quality furnace filter will be employed within the participants' homes. Information will continue to be collected about participants' health status and asthma symptoms as well as the air quality inside their homes.

Group Type: EXPERIMENTAL

Indoor Air Quality Mitigation

Intervention Type: DEVICE

Mitigation of indoor air quality with use of smart thermostat, smart bath fan control, and high quality furnace filters

Interventions

Indoor Air Quality Mitigation

Mitigation of indoor air quality with use of smart thermostat, smart bath fan control, and high quality furnace filters

Intervention Type: DEVICE

Other Intervention Names

Sensi Touch Smart Thermostat; Enbrighten Z-Wave Switch; 3M Filtrete MPR 2800 Ultrafine Particle Reduction Air Filters

Eligibility Criteria

Inclusion Criteria

Child aged 5.0-15.9 years at the time of informed consent with mild, moderate, or severe persistent asthma diagnosis. In addition, participants

• Agree to attend visits as outlined by protocol
• Agree to respond to Asthma Control Test (ACT) and asthma control questions as outlined in protocol by telephone call, text, or email.
• Are willing to comply with asthma treatment plan prescribed by physician.
• Are willing to practice an acceptable form of birth control to avoid pregnancy. Acceptable forms of birth control include: true abstinence, male or female condom with or without spermicide, female barrier contraception (such as diaphragm, cervical cap, or sponge) with spermicide, continuous use of an intrauterine device throughout the study, hormonal contraceptives (including oral, patch, implanted, or injected), if used consistently and correctly throughout the study.
• Reside in single-family dwellings and must either be homeowners or have written permission from their landlords to participate in the study.

In order to participate in the study, homes of participants must

• have working ducted forced air HVAC systems
• a 4-wire thermostat that is determined by Emerson technician to be capable of communicating with Sensi Touch Smart Thermostat
• a bathroom fan switch with neutral wire and wall plate, controlling a bathroom fan that is vented to the outdoors
• access to the internet with a modem or router.
• A smartphone capable of pairing with the Atmotube Pro wearable sensor

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairify LLC

UNKNOWN

Sponsor Role: collaborator

Copeland LP

UNKNOWN

Sponsor Role: collaborator

Dayton Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel Evans, MD

Chief, Pulmonary Medicine at Dayton Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel A. Evans, MD

Role: PRINCIPAL_INVESTIGATOR

Dayton Children's Hospital

Locations

Dayton Childrens Hospital

Dayton, Ohio, United States

Countries

United States

Other Identifiers

22-039

Identifier Type: -

Identifier Source: org_study_id