EASY: Environmental Assessment of Sleep in Youth

Sponsor

Boston Children's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03224455

Collaborator

Brigham and Women's Hospital (Other)

300

Enrollment

Location

64.3

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorders in Children Environmental Exposure

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 Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Environmental Risk Factors for Pediatric Sleep Disordered Breathing

Actual Study Start Date :

Jan 18, 2018

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

May 30, 2023

Outcome Measures

Primary Outcome Measures

Apnea Hypopnea Index (AHI) [2 days]
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.
Apnea Hypopnea Index (AHI) [7days]
Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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.