Sleep and Behavior in Children With Cleft Palate | NCT01046591

Studies
Sleep and Behavior in Children With Cleft Palate

NCT01046591

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Mar 7, 2012Estimated

Enrollment

82Actual

Phase

Not provided

Conditions

Cleft Palate

Interventions

Polysomnography

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

ID	Type	Description	Link
1R21HL087819-01A2	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2012

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

Dec 2006

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jan 11, 2010

First Submission Date that Met QC Criteria

Jan 11, 2010

First Posted Date

Jan 12, 2010Estimated

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

Mar 6, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to determine whether cleft palate repair increases the risk for obstructive sleep apnea in children and whether sleep apnea could explain learning and behavior difficulties that are often observed.

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

Not provided

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

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cleft		Those with a repaired cleft palate	Procedure: Polysomnography
Comparison		Those without a cleft palate repair	Procedure: Polysomnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polysomnography	Procedure	Overnight sleep studies will be performed on all children.	Cleft Comparison

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of obstructive sleep apnea		Within 24 hours of enrollment.

Secondary Outcomes

Measure	Description	Time Frame
Hyperactivity scores		Within 24 hours of enrollment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previous cleft palate repair
Age 6-15 years

Exclusion Criteria:

Other condition that impacts the interpretation of PSG or neurobehavioral assessments
Being treated for sleep apnea with CPAP

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Children will be recruited from cleft palate clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louise M O'Brien, PhD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D002972	Cleft Palate
D002971	Cleft Lip
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes
D001519	Behavior

Ancestor Terms

ID	Term
D007569	Jaw Abnormalities
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D019767	Maxillofacial Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided