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HAIQU (Hospital AIr QUality) (HAIQU)

25 juni 2026 bijgewerkt door: Connie B. Chang, Mayo Clinic

HAIQU (Hospital AIr QUality): Breathing Life Into Patient Care

The purpose of this research is to assess whether integration of an aerosol biosensor and air quality risk assessment software that integrates into a building management system will improve indoor air quality metrics in hospital environments and reduces risk factors associated with respiratory disease transmission.

Studie Overzicht

Toestand

Nog niet aan het werven

Interventie / Behandeling

Gedetailleerde beschrijving

Executive Summary. The Hospital AIr QUality (HAIQU) team will develop a biosensor and risk assessment software to detect pathogens in indoor air, to be integrated with building management system (BMS), focusing on improving indoor air quality in hospitals to reduce disease transmission and enhance patient outcomes. The HAIQU biosensor will combine high-flow-rate aerosol collection highly sensitive and specific CRISPR detection, and digital droplet microfluidics to continuously detect multiple viral, bacterial, and fungal pathogens from indoor air. The HAIQU risk assessment software will combine multi-scale modeling into a 'digital twin', or virtual representation of an indoor space to model pathogen distribution and exposure risk to occupants. The HAIQU tools will be applied in clinical studies within the emergency departments (EDs) of Mayo Clinic campuses in MN, WI, AZ, and FL. Integrating with building control systems, the HAIQU biosensor and software will inform strategies to mitigate bioaerosol risks, enhance productivity, save energy and costs, and protect the health of staff and patients. By ensuring clean and safe indoor air, these tools will contribute to smarter, more resilient buildings that improve cognitive performance, wellness, and overall human health.

Goals and Impact. Although people spend the majority of our time indoors, indoor air quality (IAQ) is often overlooked, with more attention given to outdoor air quality. However, clean indoor air is essential for health and well-being. Monitoring of indoor air currently lags behind other 'big data' surveillance technologies, such as wearable health monitors and disease tracking. HAIQU aims to bridge this gap by developing rapid, real-time biosensing and risk assessment tools for healthier and safer hospital buildings. Current biosensing methods are slow, non-autonomous, and limited to detecting only a few pathogens at a time. Typically, aerosol samples are collected onto a filter over two to eight hours, then manually processed for detection, often using nucleic acid amplification. For example, researchers at Mayo performed clinical trials using the Thermo Scientific AerosolSense paired with the Renvo Rapid PCR Test to detect influenza A/B, SARS-CoV-2, and RSV. Though advanced microfluidic nucleic acid amplification methods exist that are more conductive to multiplexing, combining these methods with continuous or semi-continuous aerosol collection for rapid, autonomous detection is still lacking. To detect bioaerosols which are present at very low concentrations (<1 per L), high flow rate sampling must be paired with highly sensitive, multiplexed detection methods. Here, the investigators propose the HAIQU biosensor, a portable device that enables rapid, autonomous, and near real-time bioaerosol detection. It combines high flow rate virtual impactors and condensers for aerosol capture with drop-based microfluidics, CRISPR-Cas-based detection, and multiplexed barcoding. The healthcare environment provides an ideal use case for the proposed technologies. In EDs, patients often present with undiagnosed infectious diseases that can lead to significant exposures and outbreaks among staff, patients, and visitors, sometimes only recognized after diagnosis. Detection of airborne pathogens can prevent and reduce hospital-acquired infections, which are a leading cause of illness and lost worktime.

TECHNICAL AREA 1: The final HAIQU biosensor will be capable of detecting multiple pathogens (25 real-world, viral + bacterial + fungi; 100 lab-based) with >95% sensitivity and >99% specificity, once every 45 minutes.

TECHNICAL AREA 2: HAIQU risk assessment software will include a multiscale modeling framework to predict and assess infectious disease risk in indoor environments. The multi-scale modeling framework incorporates scales from individual events to room-level and system-level information, to yield outputs and predictions of bioaerosol dispersion, infection risk, number infected, intervention recommendations, and energy calculations.

TECHNICAL AREA 3: Multi-site field trials using the HAIQU biosensor and software in Mayo Clinic's emergency departments will be performed targeting a 25% decrease in facility-related incidence of each targeted respiratory illness relative to baseline data. Biosensor data will be combined with air quality sensing data and multi-system building controls and intervention.

Studietype

Ingrijpend

Inschrijving (Geschat)

850

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85054
        • Mayo Clinic Arizona
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32224
        • Mayo Clinic Florida
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

Target Group:

  • Mayo Clinic Staff working in ED with a minimum of .7 FTE in Midwest (MN and WI), Phoenix (AZ), or Jacksonville (FL) and patient contact.

Reference Group:

  • Mayo Clinic Staff working in primary care with a minimum of .7 FTE. in Rochester (MN), Phoenix (AZ), or Jacksonville (FL) and patient contact

Exclusion Criteria:

  • Any participant who does not meet either of the inclusion criteria.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Emergency Department Employees
Emergency Department employees will act as the target group with the Emergency Department building implementing the HAIQU air quality sensor.
Participants will self-report when they are experiencing respiratory symptoms and will be asked for a self-swab to be used for data analysis.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants to experience acute respiratory infection (ARI) symptoms
Tijdsspanne: 3 years
Symptoms include: at least 2 upper respiratory symptoms for at least 24 hours; OR at least 2 symptoms that include an upper/lower respiratory symptom and a systemic symptom (fever, fatigue, body aches, headache, decreased appetite) for at least 24 hours
3 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of confirmed cases of acute respiratory infections
Tijdsspanne: 3 years
Number of cases confirmed by at least one viral panel-positive swab detected by RT-PCR
3 years
Number of confirmed cases of lower respiratory tract disease
Tijdsspanne: 3 years
Number of cases of lower respiratory tract disease confirmed by at least one viral panel-positive swab detected by RT-PCR
3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: Connie Chang, Ph.D., Mayo Clinic
  • Hoofdonderzoeker: Chung Wi, M.D., Mayo Clinic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

30 september 2029

Studie voltooiing (Geschat)

30 september 2029

Studieregistratiedata

Eerst ingediend

19 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 24-013166
  • ARPA-H-SOL-24-107 (Ander subsidie-/financieringsnummer: ARPA-H BREATHE)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data (IPD) will not be shared because the study collects detailed longitudinal health, occupational, and location-related information from Mayo Clinic employees. Although data will be coded for research purposes, the combination of respiratory health outcomes, workplace characteristics, and real-time location system (RTLS) data may increase the risk of participant re-identification. To protect participant privacy, confidentiality, and institutional data security requirements, individual-level datasets will not be made available to external researchers. Aggregate and de-identified study results will be reported through scientific publications and presentations in accordance with applicable regulations and institutional policies.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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