SleepNCT00233194
Identification of Sleep-Disordered Breathing in Children
An observational study of Sleep and Sleep Apnea Syndromes, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research is to study and improve the methods used to detect childhood breathing problems during sleep that can affect daytime behavior at home and school. Early diagnosis of these sleep disorders may allow doctors to treat children at a time when the consequences can still be reversed. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Apnea Syndromes, Sleep Disordered Breathing
- What is being tested?
- Observational follow-up study of adenotonsillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jul 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who are scheduled to undergo adenotonsillectomy for clinical indications, as well as a group of control subjects will be enrolled.
Who may be able to join
- Assent of child (if over the age of 9 or younger but able to understand the nature of the study)
- At least one parent or guardian must sign an informed consent
- Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason
- Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan
Who cannot join
- Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests
- Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines)
- Current treatment by a physician or past surgical treatment for SDB
- A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy)
- Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date
- Determination by any of the patient's physicians that sleep testing is required before surgery can be scheduled (to avoid the possibility that study enrollment itself could affect ability to complete the study)
Show all 14Show fewer
- Prior enrollment of a sibling in the study
- Expectation that the child will no longer have convenient access to University of Michigan facilities within 6 months or expectation of further surgery within that period
- Additional exclusion criteria for healthy volunteers include:
- Any history of adenoidectomy or tonsillectomy
- Plans for either procedure in the future
- History of habitual snoring
- History of large (uninfected) tonsils
- History of recurrent throat infection that might be grounds for adenotonsillectomy (three episodes in each of 3 years, five episodes in each of 2 years, or seven episodes in one year)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109-0845
About this study
The purpose of this research is to study and improve the methods used to detect childhood breathing problems during sleep that can affect daytime behavior at home and school. Early diagnosis of these sleep disorders may allow doctors to treat children at a time when the consequences can still be reversed.
Read the detailed description
BACKGROUND:
Sleep-disordered breathing (SDB) affects at least 1 to 3 percent of children. Associated morbidity can include inattentive and hyperactive behavior, disruptive behavior disorders, cognitive deficits, and excessive daytime sleepiness. Sleep specialists recommend that children undergo polysomnography to confirm SDB, especially before undergoing treatment, which often involves an adenotonsillectomy. Unfortunately, such testing is rarely performed either before or after surgery. Available data suggest that a clinical diagnosis of SDB does not predict polysomnographic results reliably. However, the extent to which polysomnographic results predict morbidity, and especially treatable morbidity, is not well known. The main goal of the proposed research, therefore, is to study and improve methods for identification of childhood SDB that carries reversible morbidity.
DESIGN NARRATIVE:
Researchers will examine the utility of polysomnography in a group of children scheduled to undergo adenotonsillectomy for clinical indications, and a group of matched control subjects. Initial evaluations, before surgery in the first group, will be compared to results of identical evaluations 6 months later in this controlled nonrandomized trial. Outcomes will be provided by well-validated assessments of behavior, psychiatric status, cognition, and sleepiness. Explanatory variables will include standard clinical and polysomnographic information, and data from two newer techniques. The first, nasal pressure monitoring, shows increased sensitivity for events that characterize SDB, but few results and no outcome data have been reported from use of this method in children. The second is an innovative signal processing algorithm developed by the investigators to show that cortical electroencephalogram (EEG) activity changes in synchrony with non-apneic respiratory cycles in children with SDB. Preliminary data suggest that the magnitude of respiratory cycle-related EEG changes (RCREC) varies with SDB severity, diminishes after SDB treatment, and improves prediction of neurobehavioral outcomes. The specific aims of the proposed research are to show that 1) nasal pressure monitoring, in comparison to standard measures of airflow, improves prediction of neurobehavioral response to adenotonsillectomy; 2) RCREC, in comparison to standard visually-scored EEG-based arousals, do likewise; 3) polysomnographic SDB measures, including nasal pressure monitoring and RCREC, add useful information to that derived from office-based assessments; and 4) polysomnography after adenotonsillectomy can identify clinically relevant residual SDB in some children.
- Conditions
- Sleep, Sleep Apnea Syndromes, Sleep Disordered Breathing
- Being tested
- Observational follow-up study of adenotonsillectomy
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational follow-up study of adenotonsillectomyProcedure or surgery
Also called Adenotonsillectomy vs. non-surgical subjects
Studies of sleep, behavior, cognition, and daytime sleepiness
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 | Children scheduled for adenotonsillectomy and healthy subjects, for comparison, not scheduled for such surgery. Receives: Procedure: Observational follow-up study of adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall behavior
Measured: Measured for approximately 6 months
Psychiatric status
Measured: Measured for approximately 6 months
Cognition
Measured: Measured for approximately 6 months
Sleepiness (measured immediately before surgery and 6 months after surgery)
Measured: Measured for approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 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, 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
- NCT00233194
- Sponsor's protocol ID
- 324
- Other IDs
- R01HL080941
- Status last verified
- Dec 2016
- First submitted
- 3 Oct 2005
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Brien LM, Lucas NH, Felt BT, Hoban TF, Ruzicka DL, Jordan R, Guire K, Chervin RD. Aggressive behavior, bullying, snoring, and sleepiness in schoolchildren. Sleep Med. 2011 Aug;12(7):652-8. doi: 10.1016/j.sleep.2010.11.012. Epub 2011 May 26.
PubMed 21620766Paruthi S, Chervin RD. Approaches to the assessment of arousals and sleep disturbance in children. Sleep Med. 2010 Aug;11(7):622-7. doi: 10.1016/j.sleep.2009.11.018.
PubMed 20620104Chervin RD, Fetterolf JL, Ruzicka DL, Thelen BJ, Burns JW. Sleep stage dynamics differ between children with and without obstructive sleep apnea. Sleep. 2009 Oct;32(10):1325-32. doi: 10.1093/sleep/32.10.1325.
PubMed 19848361Giordani B, Hodges EK, Guire KE, Ruzicka DL, Dillon JE, Weatherly RA, Garetz SL, Chervin RD. Neuropsychological and behavioral functioning in children with and without obstructive sleep apnea referred for tonsillectomy. J Int Neuropsychol Soc. 2008 Jul;14(4):571-81. doi: 10.1017/S1355617708080776.
PubMed 18577286Lumeng JC, Chervin RD. Epidemiology of pediatric obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):242-52. doi: 10.1513/pats.200708-135MG.
PubMed 18250218Dillon JE, Blunden S, Ruzicka DL, Guire KE, Champine D, Weatherly RA, Hodges EK, Giordani BJ, Chervin RD. DSM-IV diagnoses and obstructive sleep apnea in children before and 1 year after adenotonsillectomy. J Am Acad Child Adolesc Psychiatry. 2007 Nov;46(11):1425-36. doi: 10.1097/chi.0b013e31814b8eb2.
PubMed 18049292Chervin RD, Weatherly RA, Garetz SL, Ruzicka DL, Giordani BJ, Hodges EK, Dillon JE, Guire KE. Pediatric sleep questionnaire: prediction of sleep apnea and outcomes. Arch Otolaryngol Head Neck Surg. 2007 Mar;133(3):216-22. doi: 10.1001/archotol.133.3.216.
PubMed 17372077Chervin RD, Weatherly RA, Ruzicka DL, Burns JW, Giordani BJ, Dillon JE, Marcus CL, Garetz SL, Hoban TF, Guire KE. Subjective sleepiness and polysomnographic correlates in children scheduled for adenotonsillectomy vs other surgical care. Sleep. 2006 Apr;29(4):495-503.
PubMed 16676783Chervin RD, Ruzicka DL, Giordani BJ, Weatherly RA, Dillon JE, Hodges EK, Marcus CL, Guire KE. Sleep-disordered breathing, behavior, and cognition in children before and after adenotonsillectomy. Pediatrics. 2006 Apr;117(4):e769-78. doi: 10.1542/peds.2005-1837.
PubMed 16585288Chervin RD, Ruzicka DL, Archbold KH, Dillon JE. Snoring predicts hyperactivity four years later. Sleep. 2005 Jul;28(7):885-90. doi: 10.1093/sleep/28.7.885.
PubMed 16124670Chervin RD, Burns JW, Ruzicka DL. Electroencephalographic changes during respiratory cycles predict sleepiness in sleep apnea. Am J Respir Crit Care Med. 2005 Mar 15;171(6):652-8. doi: 10.1164/rccm.200408-1056OC. Epub 2004 Dec 10.
PubMed 15591467Weatherly RA, Ruzicka DL, Marriott DJ, Chervin RD. Polysomnography in children scheduled for adenotonsillectomy. Otolaryngol Head Neck Surg. 2004 Nov;131(5):727-31. doi: 10.1016/j.otohns.2004.06.699.
PubMed 15523455Chervin RD, Burns JW, Subotic NS, Roussi C, Thelen B, Ruzicka DL. Correlates of respiratory cycle-related EEG changes in children with sleep-disordered breathing. Sleep. 2004 Feb 1;27(1):116-21. doi: 10.1093/sleep/27.1.116.
PubMed 14998247Chervin RD, Burns JW, Subotic NS, Roussi C, Thelen B, Ruzicka DL. Method for detection of respiratory cycle-related EEG changes in sleep-disordered breathing. Sleep. 2004 Feb 1;27(1):110-5. doi: 10.1093/sleep/27.1.110.
PubMed 14998246Chervin RD, Ruzicka DL, Wiebelhaus JL, Hegeman GL 3rd, Marriott DJ, Marcus CL, Giordani BJ, Weatherly RA, Dillon JE. Tolerance of esophageal pressure monitoring during polysomnography in children. Sleep. 2003 Dec 15;26(8):1022-6. doi: 10.1093/sleep/26.8.1022.
PubMed 14746385
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Sleep-Disordered Breathing in Children
- ClinicalTrials.gov ID
- NCT00233194
- Acronym / sponsor ID
- 324
- Conditions
- Sleep, Sleep Apnea Syndromes, Sleep Disordered Breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Oct 2005 (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 research is to study and improve the methods used to detect childhood breathing problems during sleep that can affect daytime behavior at home and school. Early diagnosis of these sleep disorders may allow doctors to treat children at a time when the consequences can still be reversed.
Detailed description
BACKGROUND:
Sleep-disordered breathing (SDB) affects at least 1 to 3 percent of children. Associated morbidity can include inattentive and hyperactive behavior, disruptive behavior disorders, cognitive deficits, and excessive daytime sleepiness. Sleep specialists recommend that children undergo polysomnography to confirm SDB, especially before undergoing treatment, which often involves an adenotonsillectomy. Unfortunately, such testing is rarely performed either before or after surgery. Available data suggest that a clinical diagnosis of SDB does not predict polysomnographic results reliably. However, the extent to which polysomnographic results predict morbidity, and especially treatable morbidity, is not well known. The main goal of the proposed research, therefore, is to study and improve methods for identification of childhood SDB that carries reversible morbidity.
DESIGN NARRATIVE:
Researchers will examine the utility of polysomnography in a group of children scheduled to undergo adenotonsillectomy for clinical indications, and a group of matched control subjects. Initial evaluations, before surgery in the first group, will be compared to results of identical evaluations 6 months later in this controlled nonrandomized trial. Outcomes will be provided by well-validated assessments of behavior, psychiatric status, cognition, and sleepiness. Explanatory variables will include standard clinical and polysomnographic information, and data from two newer techniques. The first, nasal pressure monitoring, shows increased sensitivity for events that characterize SDB, but few results and no outcome data have been reported from use of this method in children. The second is an innovative signal processing algorithm developed by the investigators to show that cortical electroencephalogram (EEG) activity changes in synchrony with non-apneic respiratory cycles in children with SDB. Preliminary data suggest that the magnitude of respiratory cycle-related EEG changes (RCREC) varies with SDB severity, diminishes after SDB treatment, and improves prediction of neurobehavioral outcomes. The specific aims of the proposed research are to show that 1) nasal pressure monitoring, in comparison to standard measures of airflow, improves prediction of neurobehavioral response to adenotonsillectomy; 2) RCREC, in comparison to standard visually-scored EEG-based arousals, do likewise; 3) polysomnographic SDB measures, including nasal pressure monitoring and RCREC, add useful information to that derived from office-based assessments; and 4) polysomnography after adenotonsillectomy can identify clinically relevant residual SDB in some children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | – | Procedure: Observational follow-up study of adenotonsillectomyChildren scheduled for adenotonsillectomy and healthy subjects, for comparison, not scheduled for such surgery. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who are scheduled to undergo adenotonsillectomy for clinical indications, as well as a group of control subjects will be enrolled.
Key inclusion criteria (4 listed)
- Assent of child (if over the age of 9 or younger but able to understand the nature of the study)
- At least one parent or guardian must sign an informed consent
- Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason
- Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan
Key exclusion criteria (14 listed)
- Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests
- Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines)
- Current treatment by a physician or past surgical treatment for SDB
- A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy)
- Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date
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 |
|---|---|---|
| Observational follow-up study of adenotonsillectomyAlso: Adenotonsillectomy vs. non-surgical subjectsStudies of sleep, behavior, cognition, and daytime sleepiness | Procedure or surgery | Cohort 2 |
Primary outcome
Overall behavior
Time frame: Measured for approximately 6 months
Psychiatric status
Time frame: Measured for approximately 6 months
Cognition
Time frame: Measured for approximately 6 months
Sleepiness (measured immediately before surgery and 6 months after surgery)
Time frame: Measured for approximately 6 months
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 6 Dec 2016.
- Background: PubMed 21620766O'Brien LM, Lucas NH, Felt BT, Hoban TF, Ruzicka DL, Jordan R, Guire K, Chervin RD. Aggressive behavior, bullying, snoring, and sleepiness in schoolchildren. Sleep Med. 2011 Aug;12(7):652-8. doi: 10.1016/j.sleep.2010.11.012. Epub 2011 May 26.
- Background: PubMed 20620104Paruthi S, Chervin RD. Approaches to the assessment of arousals and sleep disturbance in children. Sleep Med. 2010 Aug;11(7):622-7. doi: 10.1016/j.sleep.2009.11.018.
- Background: PubMed 19848361Chervin RD, Fetterolf JL, Ruzicka DL, Thelen BJ, Burns JW. Sleep stage dynamics differ between children with and without obstructive sleep apnea. Sleep. 2009 Oct;32(10):1325-32. doi: 10.1093/sleep/32.10.1325.
- Background: PubMed 18577286Giordani B, Hodges EK, Guire KE, Ruzicka DL, Dillon JE, Weatherly RA, Garetz SL, Chervin RD. Neuropsychological and behavioral functioning in children with and without obstructive sleep apnea referred for tonsillectomy. J Int Neuropsychol Soc. 2008 Jul;14(4):571-81. doi: 10.1017/S1355617708080776.
- Background: PubMed 18250218Lumeng JC, Chervin RD. Epidemiology of pediatric obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):242-52. doi: 10.1513/pats.200708-135MG.
- Background: PubMed 18049292Dillon JE, Blunden S, Ruzicka DL, Guire KE, Champine D, Weatherly RA, Hodges EK, Giordani BJ, Chervin RD. DSM-IV diagnoses and obstructive sleep apnea in children before and 1 year after adenotonsillectomy. J Am Acad Child Adolesc Psychiatry. 2007 Nov;46(11):1425-36. doi: 10.1097/chi.0b013e31814b8eb2.
- Background: PubMed 17372077Chervin RD, Weatherly RA, Garetz SL, Ruzicka DL, Giordani BJ, Hodges EK, Dillon JE, Guire KE. Pediatric sleep questionnaire: prediction of sleep apnea and outcomes. Arch Otolaryngol Head Neck Surg. 2007 Mar;133(3):216-22. doi: 10.1001/archotol.133.3.216.
- Background: PubMed 16676783Chervin RD, Weatherly RA, Ruzicka DL, Burns JW, Giordani BJ, Dillon JE, Marcus CL, Garetz SL, Hoban TF, Guire KE. Subjective sleepiness and polysomnographic correlates in children scheduled for adenotonsillectomy vs other surgical care. Sleep. 2006 Apr;29(4):495-503.
- Background: PubMed 16585288Chervin RD, Ruzicka DL, Giordani BJ, Weatherly RA, Dillon JE, Hodges EK, Marcus CL, Guire KE. Sleep-disordered breathing, behavior, and cognition in children before and after adenotonsillectomy. Pediatrics. 2006 Apr;117(4):e769-78. doi: 10.1542/peds.2005-1837.
- Background: PubMed 16124670Chervin RD, Ruzicka DL, Archbold KH, Dillon JE. Snoring predicts hyperactivity four years later. Sleep. 2005 Jul;28(7):885-90. doi: 10.1093/sleep/28.7.885.
- Background: PubMed 15591467Chervin RD, Burns JW, Ruzicka DL. Electroencephalographic changes during respiratory cycles predict sleepiness in sleep apnea. Am J Respir Crit Care Med. 2005 Mar 15;171(6):652-8. doi: 10.1164/rccm.200408-1056OC. Epub 2004 Dec 10.
- Background: PubMed 15523455Weatherly RA, Ruzicka DL, Marriott DJ, Chervin RD. Polysomnography in children scheduled for adenotonsillectomy. Otolaryngol Head Neck Surg. 2004 Nov;131(5):727-31. doi: 10.1016/j.otohns.2004.06.699.
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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?
An observational study of Sleep 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 14 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 6 Dec 2016. 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?
Overall behavior (time frame: Measured for approximately 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00233194, which also lists 21 linked publications.
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 6 Dec 2016.