Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

NCT01554527 | Completed Results DMC

• 2 other identifiers: F029661-001R01HL105999-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Child Behavior Disorders; Attention Deficit Disorder With Hyperactivity; Disorders of Excessive Somnolence

Keywords

polysomnography; child; continuous positive airway pressure; tonsillectomy; neuropsychological tests; cognition; sleepiness; behavior

Outcome Measures

Primary Outcomes (1)

• Change in Behavioral Index After 6 Months of CPAP or No-CPAP

  The sum of the T-scores of The Conners' Parent Rating Scales (CPRS-R:L, ADHD index) and the Child Behavior Checklist (CBCL, Attention Deficit/Hyperactivity Problems) are used to construct the primary study outcome measure Behavioral Index. Behavioral index is a T score (adjusted for age and gender) with a range of "\<10" to "\>90" - where higher scores mean worse behavior and lower scores mean better behavior, so a negative change score represents an improvement in behavior. T-scores with a mean of 50 and SD of 10 are computed.

  assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Secondary Outcomes (5)

• Change in Cognition as Shown by NIH Toolbox Composite Score

  assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

• Change in Sleepiness as Measured by Epworth Sleepiness Scale

  assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

• Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT)

  assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

• Change in Quality of Life as Measured by Peds QL

  assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

• CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently.

  Starting at 4 months after AT and continuing through 10 months after AT

Other Outcomes (2)

• Change in Cognition as Measured by Fluid Cognition Scores

  assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

• Change in Cognition After AT as Shown by Academic Achievement

  assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Study Arms (2)

CPAP treatment

EXPERIMENTAL

Children randomized to this arm will receive 6 months of CPAP (or BPAP) treatment, beginning at approximately 4 months after AT, in addition to standard of care. For analysis purposes those children who were non-adherent (CPAP use \<4 hours per night) vs. adherent (CPAP use at least 4 hours per night) will be analyzed separately.

Procedure: CPAP treatment

No CPAP treatment

OTHER

Children randomized to this comparison arm will not be treated with CPAP or BPAP, but will be followed for approximately 10 months after AT while receiving standard of care.

Other: No CPAP treatment

Interventions

CPAP treatment PROCEDURE

6 months of treatment with PAP (CPAP or BPAP)

Also known as: Continuous positive airway pressure device (CPAP), Bi-level positive airway pressure device (BPAP), Positive Airway Pressure device (PAP)

CPAP treatment

No CPAP treatment OTHER

Children randomized to the comparison group will receive routine care

Also known as: Comparison group, Control group

No CPAP treatment

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 5-12 years old,
• Scheduled for an adenotonsillectomy for treatment of sleep apnea,
• Child must provide assent, and
• Parent or legal guardian must be able to speak and read English, and agree to the study.

You may not qualify if:

• No siblings of children already enrolled in the study,
• Children who expect to have another surgery (in addition to AT) during the period of participation in this study,
• Neurological, psychiatric, or medical conditions, or social factors that may affect test results, prevent children from returning for required study visits, or interfere with the study treatment, or
• Certain medications that affect sleepiness or alertness, for example:
• Stimulants (such as Ritalin, Adderall, or Concerta),
• Sleep aides (such as Melatonin, Ambien, or Ativan), or
• Sedating medicines (such as Benadryl, Klonopin, Xanax, or Valerian).

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Michigan Technological University: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Child Behavior Disorders; Attention Deficit Disorder with Hyperactivity; Disorders of Excessive Somnolence; Sleepiness; Behavior

Interventions

Continuous Positive Airway Pressure; Control Groups

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Ronald Chervin
• Organization: University of Michigan

chervin@med.umich.edu

734-647-9064

Study Officials

• Ronald D. Chervin, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: October 29, 2017
• Study Completion: October 29, 2017
• Last Updated: January 14, 2019
• Results First Posted: January 14, 2019

Record last verified: 2019-01

Locations

US (1)