Cleft PalateNCT01046591
Sleep and Behavior in Children With Cleft Palate
An observational study of Cleft Palate, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Polysomnography
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children will be recruited from cleft palate clinics
Who may be able to join
- Previous cleft palate repair
- Age 6-15 years
Who cannot join
- Other condition that impacts the interpretation of PSG or neurobehavioral assessments
- Being treated for sleep apnea with CPAP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep and Neurobehavioral Performance After Cleft Palate Repair
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.
- Conditions
- Cleft Palate
- Being tested
- Polysomnography
- Keywords
- Cleft Palate, Cleft Lip, Obstructive Sleep Apnea, Sleep-Disordered Breathing, Behavior, Learning
- Medical subject headings
- Cleft Palate, Cleft Lip, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyProcedure or surgery
Also called PSG, Overnight polysomnography
Overnight sleep studies will be performed on all children.
| Study group | Role | What they receive |
|---|---|---|
| Cleft | Those with a repaired cleft palate Receives: Procedure: Polysomnography | |
| Comparison | Those without a cleft palate repair Receives: Procedure: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of obstructive sleep apnea
Measured: Within 24 hours of enrollment.
Secondary outcomes (1)
Hyperactivity scores
Measured: Within 24 hours of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startDec 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Louise O'Brien, University of Michigan
- Investigators
- Louise M O'Brien, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046591
- Sponsor's protocol ID
- R000041
- Other IDs
- 1R21HL087819-01A2
- Status last verified
- Mar 2012
- First submitted
- 11 Jan 2010
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Neurobehavioral Performance After Cleft Palate Repair
- ClinicalTrials.gov ID
- NCT01046591
- Acronym / sponsor ID
- R000041
- Conditions
- Cleft Palate
- Keywords
- Cleft Palate, Cleft Lip, Obstructive Sleep Apnea, Sleep-Disordered Breathing, Behavior, Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleft | – | Procedure: PolysomnographyThose with a repaired cleft palate |
| Comparison | – | Procedure: PolysomnographyThose without a cleft palate repair |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children will be recruited from cleft palate clinics
Key inclusion criteria (2 listed)
- Previous cleft palate repair
- Age 6-15 years
Key exclusion criteria (2 listed)
- Other condition that impacts the interpretation of PSG or neurobehavioral assessments
- Being treated for sleep apnea with CPAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyAlso: PSG, Overnight polysomnographyOvernight sleep studies will be performed on all children. | Procedure or surgery | Cleft, Comparison |
Primary outcome
Severity of obstructive sleep apnea
Time frame: Within 24 hours of enrollment.
1 secondary outcome
Hyperactivity scores
Time frame: Within 24 hours of enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
Related trials for Cleft Palate
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Furlow With Buccinator and Fistula Formation
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Nebulized Bupivacaine Analgesia for Cleft Palate Repair
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Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise M O'Brien, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of obstructive sleep apnea (time frame: Within 24 hours of enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.