Sleep-disordered BreathingNCT00060723
Behavioral Effects of Obstructive Sleep Apnea in Children
An observational study of Sleep-disordered Breathing and Sleep Apnea, Obstructive, run by University of Michigan at 1 site in United States.
Trial summary
Sleep-disordered breathing (SDB) in children may be responsible for disruptive daytime behaviors such as inattention and hyperactivity. Many children undergo tonsillectomy for SDB and disruptive daytime behaviors. However, the link between SDB and disruptive behavior is not clearly understood. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep-disordered Breathing, Sleep Apnea, Obstructive, ADHD
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Jan 2004
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric Otolaryngology surgery practices and primary care or general surgery practices at University of Michigan and St. Joseph Mercy Health Systems
Who may be able to join
- Scheduled for adenotonsillectomy at participating local otolaryngology practices
Who cannot join
- Serious health conditions that make interpretation of sleep studies or cognitive testing difficult
- Mental or physical handicaps that prevent proper interpretation of behavioral tests
- Current treatment by a physician for SDB
- Previous surgeries for SDB, such as adenoidectomy and/or tonsillectomy or other airway-related surgeries
- Inability to schedule sleep and behavioral testing prior to surgery
- Requires sleep or behavioral testing for clinical indications
Show all 13Show fewer
- Planning to schedule additional surgeries within 1 year of study entry
- Unreliable or inconvenient access to the University of Michigan facilities within 1 year of study entry
- Additional Exclusion Criteria for Control Group
- History of large, uninfected tonsils
- History of recurrent throat infections ( > 7 infections in one year, > 5 infections in each of two years, or > 3 infections in each of 3 years)
- History of adenoidectomy, tonsillectomy, or other treatment for SDB
- Planned adenoidectomy and/or tonsillectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Behavioral Effect of Obstructive Sleep Apnea in Children
Sleep-disordered breathing (SDB) in children may be responsible for disruptive daytime behaviors such as inattention and hyperactivity. Many children undergo tonsillectomy for SDB and disruptive daytime behaviors. However, the link between SDB and disruptive behavior is not clearly understood. This study will evaluate the relationship between SDB and disruptive behavior.
Read the detailed description
While adenotonsillectomy (AT) remains one of the most common surgical procedures performed in children, indications for AT have changed in recent years. Surgeons now perform AT for suspected obstructive SDB and for daytime behaviors that may be a consequence of SDB, such as inattention and hyperactivity. However, whether SDB causes these and other disruptive behaviors is not well known. Further, the precise nature of these behaviors and what types or levels of SDB may be of concern are poorly understood. Consequently, pediatricians and otolaryngologists are not able to use objective preoperative testing to assess SDB and abnormal behavior.
This research project seeks to better define the relationship between childhood SDB and daytime behavioral problems and to determine whether SDB actually causes these behaviors. The study will better define whether inattention and hyperactivity are frequent among children who undergo AT, will identify measures and levels of SDB that are indicative of these behaviors, and will test whether improvement in SDB after AT is associated with improvement in behavior.
Five- to twelve-year-old children who have been scheduled for AT or for a control group procedure (minimally invasive, non-airway-related surgeries such as herniorraphies) will undergo behavioral assessments, cognitive tests, and structured psychiatric interviews. A secondary control group will include healthy children who are not scheduled for any type of surgery. Preoperative assessments will be used to define what behaviors are more prominent in the children scheduled for AT than in children scheduled for hernia repair. All children will undergo preoperative polysomnography to detect subtle forms of SDB that may be particularly prevalent in children. Children will also undergo assessments after surgery.
Children will be scheduled for two or three study visits, depending on whether participants agreed to an optional 3-month interim assessment. Children will be followed for approximately 1 year from the date of surgery.
- Conditions
- Sleep-disordered Breathing, Sleep Apnea, Obstructive, ADHD
- Keywords
- Polysomnography, Sleep-disordered breathing, Sleep apnea, obstructive, Hyperactivity, Sleep, Child
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adenotonsillectomy group | Children ages 5-12 who are scheduled for adenotonsillectomy for obstructive sleep apnea | |
| Comparison group | Children ages 5-12, scheduled for hernia repairs, other procedures not involving the head, chest or neck, or no procedures. Additional exclusions include children with a history of recurrent throat infections, large tonsils, history of or plans for adenoidectomy and/or tonsillectomy or who have been previously diagnosed with sleep-disordered breathing. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2003 (estimated)
- Study startAug 1999
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sleep-disordered BreathingStudies 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
- 106 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
- NCT00060723
- Sponsor's protocol ID
- 5R01HD38461-3
- Other IDs
- 5R01HD038461
- Status last verified
- Dec 2016
- First submitted
- 9 May 2003
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weatherly RA, Mai EF, Ruzicka DL, Chervin RD. Identification and evaluation of obstructive sleep apnea prior to adenotonsillectomy in children: a survey of practice patterns. Sleep Med. 2003 Jul;4(4):297-307. doi: 10.1016/s1389-9457(03)00100-x.
PubMed 14592302Chervin 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 14746385Archbold KH, Giordani B, Ruzicka DL, Chervin RD. Cognitive executive dysfunction in children with mild sleep-disordered breathing. Biol Res Nurs. 2004 Jan;5(3):168-76. doi: 10.1177/1099800403260261.
PubMed 14737917Chervin 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, 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 14998247Giordani B, Hodges EK, Guire KE, Ruzicka DL, Dillon JE, Weatherly RA, Garetz SL, Chervin RD. Changes in neuropsychological and behavioral functioning in children with and without obstructive sleep apnea following Tonsillectomy. J Int Neuropsychol Soc. 2012 Mar;18(2):212-22. doi: 10.1017/S1355617711001743. Epub 2012 Jan 25.
PubMed 22272653Giordani 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 18577286Dillon 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 16585288
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
- Behavioral Effect of Obstructive Sleep Apnea in Children
- ClinicalTrials.gov ID
- NCT00060723
- Acronym / sponsor ID
- 5R01HD38461-3
- Conditions
- Sleep-disordered Breathing, Sleep Apnea, Obstructive, ADHD
- Keywords
- Polysomnography, Sleep-disordered breathing, Sleep apnea, obstructive, Hyperactivity, Sleep, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1999
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 13 May 2003 (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.
Sleep-disordered breathing (SDB) in children may be responsible for disruptive daytime behaviors such as inattention and hyperactivity. Many children undergo tonsillectomy for SDB and disruptive daytime behaviors. However, the link between SDB and disruptive behavior is not clearly understood. This study will evaluate the relationship between SDB and disruptive behavior.
Detailed description
While adenotonsillectomy (AT) remains one of the most common surgical procedures performed in children, indications for AT have changed in recent years. Surgeons now perform AT for suspected obstructive SDB and for daytime behaviors that may be a consequence of SDB, such as inattention and hyperactivity. However, whether SDB causes these and other disruptive behaviors is not well known. Further, the precise nature of these behaviors and what types or levels of SDB may be of concern are poorly understood. Consequently, pediatricians and otolaryngologists are not able to use objective preoperative testing to assess SDB and abnormal behavior.
This research project seeks to better define the relationship between childhood SDB and daytime behavioral problems and to determine whether SDB actually causes these behaviors. The study will better define whether inattention and hyperactivity are frequent among children who undergo AT, will identify measures and levels of SDB that are indicative of these behaviors, and will test whether improvement in SDB after AT is associated with improvement in behavior.
Five- to twelve-year-old children who have been scheduled for AT or for a control group procedure (minimally invasive, non-airway-related surgeries such as herniorraphies) will undergo behavioral assessments, cognitive tests, and structured psychiatric interviews. A secondary control group will include healthy children who are not scheduled for any type of surgery. Preoperative assessments will be used to define what behaviors are more prominent in the children scheduled for AT than in children scheduled for hernia repair. All children will undergo preoperative polysomnography to detect subtle forms of SDB that may be particularly prevalent in children. Children will also undergo assessments after surgery.
Children will be scheduled for two or three study visits, depending on whether participants agreed to an optional 3-month interim assessment. Children will be followed for approximately 1 year from the date of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenotonsillectomy group | – | –Children ages 5-12 who are scheduled for adenotonsillectomy for obstructive sleep apnea |
| Comparison group | – | –Children ages 5-12, scheduled for hernia repairs, other procedures not involving the head, chest or neck, or no procedures. Additional exclusions include children with a history of recurrent throat infections, large tonsils, history of or plans for adenoidectomy and/or tonsillectomy or who have been previously diagnosed with sleep-disordered breathing. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric Otolaryngology surgery practices and primary care or general surgery practices at University of Michigan and St. Joseph Mercy Health Systems
Key inclusion criteria (1 listed)
- Scheduled for adenotonsillectomy at participating local otolaryngology practices
Key exclusion criteria (13 listed)
- Serious health conditions that make interpretation of sleep studies or cognitive testing difficult
- Mental or physical handicaps that prevent proper interpretation of behavioral tests
- Current treatment by a physician for SDB
- Previous surgeries for SDB, such as adenoidectomy and/or tonsillectomy or other airway-related surgeries
- Inability to schedule sleep and behavioral testing prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14592302Weatherly RA, Mai EF, Ruzicka DL, Chervin RD. Identification and evaluation of obstructive sleep apnea prior to adenotonsillectomy in children: a survey of practice patterns. Sleep Med. 2003 Jul;4(4):297-307. doi: 10.1016/s1389-9457(03)00100-x.
- Background: PubMed 14746385Chervin 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.
- Background: PubMed 14737917Archbold KH, Giordani B, Ruzicka DL, Chervin RD. Cognitive executive dysfunction in children with mild sleep-disordered breathing. Biol Res Nurs. 2004 Jan;5(3):168-76. doi: 10.1177/1099800403260261.
- Background: PubMed 14998246Chervin 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.
- Background: PubMed 14998247Chervin 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.
- Results publication: PubMed 22272653Giordani B, Hodges EK, Guire KE, Ruzicka DL, Dillon JE, Weatherly RA, Garetz SL, Chervin RD. Changes in neuropsychological and behavioral functioning in children with and without obstructive sleep apnea following Tonsillectomy. J Int Neuropsychol Soc. 2012 Mar;18(2):212-22. doi: 10.1017/S1355617711001743. Epub 2012 Jan 25.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
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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-disordered Breathing and Sleep Apnea, Obstructive, 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 1 inclusion and 13 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060723, which also lists 11 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.