Environmental Assessment of Sleep in Youth

Environmental Exposure Clinical Trial

— EASY  

Official title:

Environmental Risk Factors for Pediatric Sleep Disordered Breathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224455
• Other study ID #: IRB-P00025433
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: June 17, 2023

Study information

• Verified date: June 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 17, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Environmental Exposure
• Sleep Disorders in Children
• Sleep Wake Disorders

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Apnea Hypopnea Index (AHI)	Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.	7days
Secondary	sleep duration and sleep efficiency	average of the sleep sensor readings	7 days
Secondary	Sleepiness Quality of Life	total score of Epworth Sleepiness Scale(ESS)	7 days
Secondary	Quality of Life score	total score of Pediatric Quality of Life (PedsQL) (0-100) 100 is better outcome	7 days