Environmental Assessment of Sleep in Youth | NCT03224455

Studies
Environmental Assessment of Sleep in Youth

NCT03224455

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Nov 26, 2024Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Sleep Disorders in Children
Environmental Exposure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2018Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 17, 2023Actual

First Submitted Date

Jul 17, 2017

First Submission Date that Met QC Criteria

Jul 19, 2017

First Posted Date

Jul 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2024

Last Update Posted Date

Nov 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wanda Phipatanakul, Professor of Pediatrics, Harvard Medical School (HMS and HSDM)Principal Investigator

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

Name	Class
Brigham and Women's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wanda Phipatanakul, MS. MS.	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Children's Hospital		Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided