Revisiting Parental Survey for Screening for Obstructive... | NCT01914198

Studies
Revisiting Parental Survey for Screening for Obstructive Sleep Apnea in Patients Undergoing Polysomnography

NCT01914198

Sponsor

Vidya Raman

Status

Completed

Last Update Posted

Jan 5, 2018Actual

Enrollment

948Actual

Phase

Not provided

Conditions

Sleep Apnea

Interventions

Sleep apnea symptom survey

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

Jan 2018

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

Aug 2013

Primary Completion Date

Sep 13, 2016Actual

Completion Date

Sep 13, 2016Actual

First Submitted Date

Jul 31, 2013

First Submission Date that Met QC Criteria

Aug 1, 2013

First Posted Date

Aug 2, 2013Estimated

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

Jan 3, 2018

Last Update Posted Date

Jan 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The investigators are proposing a study where the investigators would give a survey to the parents of patients having a sleep study. The survey would contain questions relating to symptoms of sleep apnea and then the investigators would correlate the parent answers to the results of the sleep study.

Detailed Description

Not provided

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

948Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep study		Patients who are having a sleep study done at NCH to diagnose sleep apnea.	Other: Sleep apnea symptom survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep apnea symptom survey	Other	Parents or caregivers will complete a questionnaire regarding possible sleep apnea symptoms.	Sleep study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep apnea symptoms	Parents or caregivers will be asked to complete a questionnaire regarding possible symptoms related to sleep apnea.	1 Day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient coming for sleep study at Nationwide Children's Hospital and parent willing to fill out questionnaire.
Children ages 3-18 years old regardless of sex or race.

Exclusion Criteria:

Parental refusal.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients who are having a sleep study at NCH.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided