Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

NCT ID: NCT01554527

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-10-29

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.

Detailed Description

Obstructive sleep-disordered breathing (SDB) affects at least 2-3% of children and may have substantial adverse impact on behavior and cognition. Adenotonsillectomy (AT), the second most common surgical procedure in children, is now performed more often for suspected SDB than for any other indication. However, recent studies among an increasingly obese population now show something alarming: many if not most children still have SDB after AT, and many still suffer from residual neurobehavioral morbidity. Furthermore, the investigators' ongoing, 12-year, NIH-funded research has shown that standard preoperative polysomnographic measures of SDB do not consistently predict post-AT improvement in behavior and cognition. This may arise in part because many children after AT still have SDB, and because linear relationships between standard SDB measures and neurobehavioral morbidity may not exist. Even at subtle levels, SDB may promote significant neurobehavioral morbidity. Some have suggested that polysomnography may be more important after AT than before AT. However, in practice few children receive polysomnography before AT, and even fewer after AT, when continuous positive airway pressure (CPAP) could still provide definitive relief from SDB. Preliminary data from our group suggest that CPAP after AT is well-tolerated by most children and may provide significant benefit. However, virtually no published evidence exists to address critical clinical questions: which children benefit most from CPAP after AT; what role can clinical symptoms or polysomnography play in that determination; and what neurobehavioral gains are achieved by CPAP after AT?

The investigators therefore will undertake a highly practical, clinical study with two main goals: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with CPAP after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment. This research will use reversible SDB-related neurobehavioral morbidity as the criteria by which to judge the utility of clinical symptoms and polysomnography in identification of candidates for CPAP after AT.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP treatment

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.

Group Type: EXPERIMENTAL

CPAP treatment

Intervention Type: PROCEDURE

6 months of treatment with PAP (CPAP or BPAP)

No CPAP treatment

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.

Group Type: OTHER

No CPAP treatment

Intervention Type: OTHER

Children randomized to the comparison group will receive routine care

Interventions

CPAP treatment

6 months of treatment with PAP (CPAP or BPAP)

Intervention Type: PROCEDURE

No CPAP treatment

Children randomized to the comparison group will receive routine care

Intervention Type: OTHER

Other Intervention Names

Continuous positive airway pressure device (CPAP); Bi-level positive airway pressure device (BPAP); Positive Airway Pressure device (PAP); Comparison group; Control group

Eligibility Criteria

Inclusion Criteria

1. Children ages 5-12 years old,

2. Scheduled for an adenotonsillectomy for treatment of sleep apnea,

3. Child must provide assent, and

4. Parent or legal guardian must be able to speak and read English, and agree to the study.

Exclusion Criteria

1. No siblings of children already enrolled in the study,

2. Children who expect to have another surgery (in addition to AT) during the period of participation in this study,

3. 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

4. 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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Michigan Technological University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ronald D. Chervin, M.D., M.S.

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald D. Chervin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01HL105999-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F029661-00

Identifier Type: -

Identifier Source: org_study_id