Sleep Apnea, ObstructiveNCT01554527
Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
A study testing CPAP treatment and No CPAP treatment in people with Sleep Apnea, Obstructive and Sleep Apnea Syndromes, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Child Behavior Disorders
- What is being tested?
- CPAP treatment and No CPAP treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 29 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children
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.
Read the 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
- Being tested
- CPAP treatment, No CPAP treatment
- Keywords
- polysomnography, child, continuous positive airway pressure, tonsillectomy, neuropsychological tests, cognition, sleepiness, behavior
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Child Behavior Disorders, Attention Deficit Disorder with Hyperactivity, Disorders of Excessive Somnolence, Sleepiness, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentProcedure or surgery
Also called Continuous positive airway pressure device (CPAP), Bi-level positive airway pressure device (BPAP), Positive Airway Pressure device (PAP)
6 months of treatment with PAP (CPAP or BPAP)
No CPAP treatmentOther
Also called Comparison group, Control group
Children randomized to the comparison group will receive routine care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40 and Maximum value 160. Higher scores are better
Measured: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Change in Sleepiness as Measured by Epworth Sleepiness Scale
Epworth Sleepiness Scale scores range from 0 to 24 where higher scores mean greater sleepiness.
Measured: 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)
Multiple Sleep Latency Test (MSLT) is an objective measure of sleepiness determined by measure of brain waves and other physiological signals over a 30 minute period. This is measured for five 30 minute periods across the day and average latency to sleep for each participant across those times were used to calculate the mean sleep latency. The score is measured in how quickly one would fall asleep, measured in minutes, so a negative number of minutes in the change score means that participants fell asleep more quickly than previously.
Measured: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Change in Quality of Life as Measured by Peds QL
Peds-QL is a quality of life symptom measurement with a score range of 0 to 100. Higher scores are better quality of life
Measured: 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.
CPAP adherence data will be downloaded from CPAP machines. It is defined for this study as using the CPAP machine for at least an average of 4 hours per night during the last 60 days of the assignment.
Measured: Starting at 4 months after AT and continuing through 10 months after AT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion29 Oct 2017
- Study completion29 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Michigan Technological University
- Responsible party
- Principal investigator, Ronald D. Chervin, M.D., M.S., University of Michigan
- Investigators
- Ronald D. Chervin, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554527
- Sponsor's protocol ID
- F029661-00
- Other IDs
- 1R01HL105999-01A1
- Status last verified
- Jan 2019
- First submitted
- 1 Mar 2012
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children
- ClinicalTrials.gov ID
- NCT01554527
- Acronym / sponsor ID
- F029661-00
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Michigan Technological University
- Study start
- Mar 2012
- Primary completion
- 29 Oct 2017 (actual)
- Study completion
- 29 Oct 2017 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 14 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Procedure: CPAP treatmentChildren 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. |
| No CPAP treatment | Other | Other: No CPAP treatmentChildren 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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:
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 |
|---|---|---|
| CPAP treatmentAlso: Continuous positive airway pressure device (CPAP), Bi-level positive airway pressure device (BPAP), Positive Airway Pressure device (PAP)6 months of treatment with PAP (CPAP or BPAP) | Procedure or surgery | CPAP treatment |
| No CPAP treatmentAlso: Comparison group, Control groupChildren randomized to the comparison group will receive routine care | Other | No CPAP treatment |
Primary outcome
Change in Behavioral Index After 6 Months of CPAP or No-CPAP
Time frame: assessed as change from baseline to 6 months of CPAP therapy 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.
5 secondary outcomes
Change in Cognition as Shown by NIH Toolbox Composite Score
Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Change in Sleepiness as Measured by Epworth Sleepiness Scale
Time frame: 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)
Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Change in Quality of Life as Measured by Peds QL
Time frame: 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.
Time frame: Starting at 4 months after AT and continuing through 10 months after AT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronald D. Chervin, MD, MS 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?
A study testing CPAP treatment and No CPAP treatment in people with Sleep Apnea, Obstructive and Sleep Apnea Syndromes, 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 4 inclusion and 7 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 14 Jan 2019. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Behavioral Index After 6 Months of CPAP or No-CPAP (time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP). 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 14 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.