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Environmental Assessment of Sleep in Youth

Environmental Risk Factors for Pediatric Sleep Disordered Breathing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03224455
Acronym
EASY
Enrollment
300
Registered
2017-07-21
Start date
2018-01-18
Completion date
2023-06-17
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environmental Exposure, Sleep Disorders in Children

Keywords

sleep, sleep in children, children and sleep, environment, environment and sleep, environment and children

Brief summary

In this research study, investigators want to learn more about the factors that influence children's breathing during sleep and their sleep quality. Specifically, investigators are interested in factors that are related to risk of snoring, sleep apnea (a condition where breathing stops during sleep), and poor sleep quality.

Detailed description

Investigators are doing a research study to gather information to help better understand why snoring and sleep problems are so common in the community, and how the home and neighborhood environment impacts sleep in children. Investigators want to know if factors such as the quality of air, household dust, environmental noise, and family routines impact sleep and other health and behavioral factors associated with sleep. Investigators want to test how sleep is influenced by factors such as: the quality of air inside and outside the child's home (including measuring pollution, second hand smoke, and dust); temperature and humidity; family routines and interactions; and characteristics of the home. Investigators will ask participants to come in for a one time visit for undergoing procedures as well as answering questions regarding general health, asthma and sleep. 10% of the participating children will have a second home assessment and sleep monitoring procedures performed 6 months after the initial home assessment.

Interventions

None listed

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 6-12 years * Children living (50% of the time or more) at their current residence for at least 1 month

Exclusion criteria

* Children with severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility) * Children with severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance * Children living in the current residence for \< 1 month will be not be eligible. * Families who do not speak English or Spanish well enough to complete the neuropsychological measures, as validated versions in other languages are not available for all of the measures.

Design outcomes

Primary

MeasureTime frameDescription
Apnea Hypopnea Index (AHI)2 daysOxygen Desaturation Index (ODI; \>3%desaturation dips) registered in the WatchPAT. Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.

Secondary

MeasureTime frameDescription
sleep duration and sleep efficiency7 daysaverage of the sleep sensor readings
Sleepiness Quality of Life7 daystotal score of Epworth Sleepiness Scale(ESS)
Quality of Life score7 daystotal score of Pediatric Quality of Life (PedsQL) (0-100) 100 is better outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026