Recruiting

Smart Inhaler

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06783101

Conditions

Asthma in Children

Intellectual Disabilities (F70-F79)

Developmental Disability

Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Use of smart inhaler to enhance asthma inhaler proficiency

Study Details

Brief summary:

Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.

Conditions

Asthma in Children

Intellectual Disabilities (F70-F79)

Developmental Disability

Autism Spectrum Disorder (ASD)

Study ID

NCT06783101

Start date

Aug 13, 2024

Status verified date

Jan, 2025

Completion date

Apr, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study:

  • Adolescents ages 10-17 years
  • Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89
  • Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909
  • Parent/legal guardian is willing to answer questions about their child.
  • Parent/legal guardian and adolescent must have the ability to understand study procedures and to comply with them for the entire length of the study
  • English or Spanish-speaking participants
  • Not involved in other studies using digital inhalers
  • Males and females of reproductive capability will be enrolled: contraception is not necessary or required.
  • Participants must use any of the following MDIs (as indicated by the 510(k): Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.

Exclusion Criteria: All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:

  • Health status or any clinical conditions: Limited life expectancy, co-existing disease or other characteristics that precludes appropriate diagnosis, treatment, or follow-up in the trial.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Standard asthma education arm

experimental: Intervention

Uses smart inhaler daily for 8 weeks

Interventions

Use of smart inhaler to enhance asthma inhaler proficiency

The application of the smart inhaler technology to enhance asthma inhaler proficiency

Primary outcome measure

  • Feasibility of smart inhaler device [ Time Frame: Weeks 1-8 ]
  • Acceptability of smart inhaler [ Time Frame: Weeks 4 and 8 ]
  • Usability of smart inhaler [ Time Frame: Weeks 4 and 8 ]

Central Contacts and Locations

Central contacts

Sophia Park, MD

323-669-2534soppark@chla.usc.edu

Alexis Deavenport-Saman, DrPH, MPH

323-361-2994adeavenport@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Sophia Park, MD

323-669-2534soppark@chla.usc.edu

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Jan 20, 2025

Last verified

Jan, 2025

Keywords

  • smart inhaler
  • asthma
  • inhaler proficiency
  • children
  • intellectual disability
  • developmental disability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-01-20.