Environmental Assessment of Sleep in Youth (EASY)

Environmental Risk Factors for Pediatric Sleep Disordered Breathing

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.

Study Overview

• Status: Completed
• Conditions: Environmental Exposure; Sleep Disorders in Children

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children 6-12 years old who live in the Boston area.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index (AHI)	Oxygen 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.	2 days
Apnea Hypopnea Index (AHI)	Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.	7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep duration and sleep efficiency	average of the sleep sensor readings	7 days
Sleepiness Quality of Life	total score of Epworth Sleepiness Scale(ESS)	7 days
Quality of Life score	total score of Pediatric Quality of Life (PedsQL) (0-100) 100 is better outcome	7 days

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: Wanda Phipatanakul, MS. MS., Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 17, 2023

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: sleep; environment; environment and children; sleep in children; children and sleep; environment and sleep
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: IRB-P00025433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No