Clinical trial NCT03224455: Environmental Assessment of Sleep in Youth
Official title: Environmental Risk Factors for Pediatric Sleep Disordered Breathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders in Children
Environmental Exposure
Keywords: sleep
sleep in children
children and sleep
environment
environment and sleep
environment and children
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2017-07-21
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 6-12 years old who live in the Boston area.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 2 days
measure: Apnea Hypopnea Index (AHI)
timeFrame: 7days
Secondary outcomes:
measure: sleep duration and sleep efficiency
timeFrame: 7 days
measure: Sleepiness Quality of Life
timeFrame: 7 days
measure: Quality of Life score
timeFrame: 7 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Wanda Phipatanakul, MS. MS.
role: PRINCIPAL_INVESTIGATOR
References: