http://dx.doi.org/10.5665/sleep.1388

Susan Redline, MD, MPH¹; Raouf Amin, MD²; Dean Beebe, PhD²; Ronald D. Chervin, MD, MS³; Susan L. Garetz, MD⁴; Bruno Giordani, PhD⁵; Carole L. Marcus, MBBCh⁶; Renee H. Moore, PhD⁷; Carol L. Rosen, MD⁸; Raanan Arens, MD⁹; David Gozal, MD¹⁰; Eliot S. Katz, MD¹¹; Ronald B. Mitchell, MD, PhD¹²; Hiren Muzumdar, MD⁹; H.G. Taylor, PhD⁸; Nina Thomas, PhD¹³; Susan Ellenberg, PhD⁷

¹Division of Sleep Medicine, Harvard Medical School, Brigham and Women's Hospital and Beth Israel Medical Center, Boston, MA; ²Children's Hospital Medical Center, Cincinnati, OH; ³Sleep Disorders Center and Department of Neurology, University of Michigan, Ann Arbor, MI; ⁴Department of Otolaryngology/Head and Neck Surgery, University of Michigan Health System, Ann Arbor, MI; ⁵Neuropsychology Section, Departments of Psychiatry, Neurology, and Psychology, University of Michigan, Ann Arbor, MI; ⁶Sleep Center, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA; ⁷Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA; ⁸Department of Pediatrics, Case Western Reserve University School of Medicine, University Hospitals-Case Medical Center, Rainbow Babies and Children' Hospital, Cleveland, OH; ⁹Children's Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, NY; ¹⁰Department of Pediatrics, Comer Children's Hospital, Pritzker School of Medicine, The University of Chicago, Chicago, IL; ¹¹Division of Respiratory Diseases, Harvard Medical School, Children's Hospital, Boston, Boston, MA; ¹²Pediatric Otolaryngology, Saint Louis University School of Medicine, Cardinal Glennon Children's Medical Center, St Louis, MO; ¹³Neuropsychology & Assessment, Department of Child and Adolescent Psychiatry and Behavioral Science, Children's Hospital of Philadelphia, Philadelphia, PA

VOLUME 34, ISSUE 11 Previous Article Next Article Genetic Underpinnings of Obstructive Sleep Apnea: Are We Making Progress?. 1449-1452. Patrick Sleiman, PhD1,2; Hakon Hakonarson, MD, PhD1,2,3 Searching for the Missing Heritability. 1453-1454. Nathaniel F. Watson, MD, MSc Back to the Future or Forward to the Past?. 1455-1456. Samuel T. Kuna, MD Are Short Bad Sleep Nights a Hindrance to a Healthy Heart?. 1457-1458. Francesco P. Cappuccio, FRCP, FFPH; Michelle A. Miller, PhD, FFPH Toward a Multi-Level Approach to CPAP Adherence. 1459-1460. Alec B. Platt, MD, MSCE1,2; Nirav P. Patel, MD, MPH1,2 A Review of Genetic Association Studies of Obstructive Sleep Apnea: Field Synopsis and Meta-Analysis. 1461-1468. Vasileia Varvarigou, MD1,2; Issa J. Dahabreh, MD3; Atul Malhotra, MD4; Stefanos N. Kales, MD, MPH1,2 Identification of Causal Genes, Networks, and Transcriptional Regulators of REM Sleep and Wake. 1469-1477. Joshua Millstein, PhD1; Christopher J. Winrow, PhD2; Andrew Kasarskis, PhD3; Joseph R. Owens, BE4; Lili Zhou, BS4; Keith C. Summa, BS4; Karrie Fitzpatrick, BS4; Bin Zhang, PhD1; Martha H. Vitaterna, PhD4; Eric E. Schadt, PhD3; John J. Renger, PhD2; Fred W. Turek, PhD4 Treating Obstructive Sleep Apnea with Hypoglossal Nerve Stimulation. 1479-1486. Peter R. Eastwood, PhD1,2; Maree Barnes, MBBS3; Jennifer H. Walsh, PhD1,2; Kathleen J. Maddison, BSc1,2; Geoffrey Hee, MBBS; Alan R. Schwartz, MD5; Philip L. Smith, MD5; Atul Malhotra, MD6; R. Douglas McEvoy, MBBS7,11,15; John R. Wheatley, MBBS, PhD8; Fergal J. O'Donoghue, MBBS, PhD3,4; Peter D. Rochford, BAppSc, GradDip (Bio Instr)3,9; Tom Churchward, RPSGT3; Matthew C. Campbell, MBBS3; Carsten E. Palme, MBBS10; Sam Robinson, MBBS11; George S. Goding, MD12; Danny J. Eckert, PhD13; Amy S. Jordan, PhD4; Peter G. Catcheside, PhD7,11,15; Louise Tyler, RN, RPSGT8,14; Nick A. Antic, MBBS, PhD7,11,15; Christopher J. Worsnop, MBBS, PhD3,4; Eric J. Kezirian, MD, MPH16; David R. Hillman, MBBS1 Sleep Duration and Sleep Quality in Relation to 12-Year Cardiovascular Disease Incidence: The MORGEN Study. 1487-1492. Marieke P. Hoevenaar-Blom, MSc1,2; Annemieke M.W. Spijkerman, PhD1; Daan Kromhout, MPH, PhD2; Julia F. van den Berg, PhD3; W.M. Monique Verschuren, PhD1 Poor Sleep Quality is Associated with Preterm Birth. 1493-1498. Michele L. Okun, PhD1; Christine Dunkel Schetter, PhD2; Laura M. Glynn, PhD3,4 Poor Sleep Quality Predicts Deficient Emotion Information Processing over Time in Early Adolescence. 1499-1508. Nirit Soffer-Dudek, PhD1; Avi Sadeh, DSc1; Ronald E. Dahl, MD2; Shiran Rosenblat-Stein, MA1 The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population. 1509-1517. Susan Redline, MD, MPH1; Raouf Amin, MD2; Dean Beebe, PhD2; Ronald D. Chervin, MD, MS3; Susan L. Garetz, MD4; Bruno Giordani, PhD5; Carole L. Marcus, MBBCh6; Renee H. Moore, PhD7; Carol L. Rosen, MD8; Raanan Arens, MD9; David Gozal, MD10; Eliot S. Katz, MD11; Ronald B. Mitchell, MD, PhD12; Hiren Muzumdar, MD9; H.G. Taylor, PhD8; Nina Thomas, PhD13; Susan Ellenberg, PhD7 Loneliness Is Associated with Sleep Fragmentation in a Communal Society. 1519-1526. Lianne M. Kurina, PhD1; Kristen L. Knutson, PhD2; Louise C. Hawkley, PhD3; John T. Cacioppo, PhD3; Diane S. Lauderdale, PhD1; Carole Ober, PhD4 State-Dependent Changes in Cortical Gain Control as Measured by Auditory Evoked Responses to Varying Intensity Stimuli. 1527-1537. Derrick J. Phillips, BS1; Jennifer L. Schei, PhD2; Peter C. Meighan, PhD1; David M. Rector, PhD1 Antagonizing Corticotropin-Releasing Factor in the Central Nucleus of the Amygdala Attenuates Fear-induced Reductions in Sleep but not Freezing. 1539-1549. Xianling Liu, MD, PhD; Laurie L. Wellman, PhD; Linghui Yang, MS; Marta A. Ambrozewicz, MD, PhD; Xiangdong Tang, MD, PhD; Larry D. Sanford, PhD Sleep-Stage Dynamics in Patients with Chronic Fatigue Syndrome with or without Fibromyalgia. 1551-1560. Akifumi Kishi, PhD1,2,3; Benjamin H. Natelson, MD4; Fumiharu Togo, PhD5; Zbigniew R. Struzik, PhD1; David M. Rapoport, MD3; Yoshiharu Yamamoto, PhD1 Evaluation of the Association of Menopausal Status with Delta and Beta EEG Activity during Sleep. 1561-1568. Ian G. Campbell, PhD1; Joyce T. Bromberger, PhD2,3; Daniel J. Buysse, MD3; Martica H. Hall, PhD3; Kimberly A. Hardin, MD4; Howard M. Kravitz, DO, MPH5; Karen A. Matthews, PhD2,3; Marianne O'Neill Rasor, MA6; Jessica Utts, PhD7; Ellen Gold, PhD6 Quantification of the Fragmentation of Rest-Activity Patterns in Elderly Individuals Using a State Transition Analysis. 1569-1581. Andrew S.P. Lim, MD1; Lei Yu, PhD2; Madalena D. Costa, PhD3,4; Aron S. Buchman, MD2; David A. Bennett, MD2; Sue E. Leurgans, PhD2; Clifford B. Saper, MD, PhD1 Self-Reported Sleep Duration and Time in Bed as Predictors of Physical Function Decline: Results from the InCHIANTI Study. 1583-1593. Sari Stenholm, PhD1; Erkki Kronholm, PhD2; Stefania Bandinelli, MD3; Jack M. Guralnik, MD, PhD4; Luigi Ferrucci, MD, PhD5 Ethnic Disparities in CPAP Adherence in New Zealand: Effects of Socioeconomic Status, Health Literacy and Self-Efficacy. 1595-1603. Jessie P. Bakker, PhD; Karyn M. O'Keeffe, BSc (Hons); Alister M. Neill, FRACP, MD; Angela J. Campbell, PhD Increased Aortic Root Size is Associated with Nocturnal Hypoxia and Diastolic Blood Pressure in Obstructive Sleep Apnea. 1605-1607. Jean-Philippe Baguet, MD, PhD1,2; Caroline Minville, MD3,4; Renaud Tamisier, MD, PhD3,4; Frederic Roche, MD, PhD5; Gilles Barone-Rochette, MD1,2; Olivier Ormezzano, MD, PhD1,2; Patrick Levy, MD, PhD3,4; Jean-Louis Pepin, MD, PhD3,4 Erratum. 1608. Ronald C. Kessler, PhD  Table of Contents

Text size:

Each year, over 500,000 adenotonsillectomies (AT), mostly for the treatment of pediatric obstructive sleep apnea (OSA) are performed in the US in children under 15 years of age. No definitive study, however, has been yet conducted that has rigorously evaluated the effectiveness of AT for not only improving sleep disordered breathing, but also for improving clinically relevant outcomes, such as neurocognitive function, behavior, and quality of life. The Childhood Adenotonsillectomy Trial (CHAT) was designed to assess neuropsychological and health outcomes in children randomized to receive early AT (eAT) as compared to Watchful Waiting with Supportive Care (WWSC). Important secondary goals of the study are to evaluate outcomes in subgroups defined by obesity and race. This paper addresses key elements in the design and implementation of a controlled trial for a widely used “standard practice” surgical intervention in a pediatric population, that include establishment of standardized data collection procedures across sites for a wide variety of data types, establishment of equipoise, and approaches for minimizing unblinding of selected key personnel. The study framework that was established should provide a useful template for other pediatric controlled studies or other studies that evaluate surgical interventions.

Citation:

Redline S; Amin R; Beebe D; Chervin RD; Garetz SL; Giordani B; Marcus CL; Moore RH; Rosen CL; Arens R; Gozal D; Katz ES; Mitchell RB; Muzumdar H; Taylor HG; Thomas N; Ellenberg S. The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population. SLEEP 2011;34(11):1509-1517.

VOLUME 34, ISSUE 11

Previous Article

Next Article

Genetic Underpinnings of Obstructive Sleep Apnea: Are We Making Progress?. 1449-1452.
Patrick Sleiman, PhD^1,2; Hakon Hakonarson, MD, PhD^1,2,3

Searching for the Missing Heritability. 1453-1454.
Nathaniel F. Watson, MD, MSc

Back to the Future or Forward to the Past?. 1455-1456.
Samuel T. Kuna, MD

Are Short Bad Sleep Nights a Hindrance to a Healthy Heart?. 1457-1458.
Francesco P. Cappuccio, FRCP, FFPH; Michelle A. Miller, PhD, FFPH

Toward a Multi-Level Approach to CPAP Adherence. 1459-1460.
Alec B. Platt, MD, MSCE^1,2; Nirav P. Patel, MD, MPH^1,2

A Review of Genetic Association Studies of Obstructive Sleep Apnea: Field Synopsis and Meta-Analysis. 1461-1468.
Vasileia Varvarigou, MD^1,2; Issa J. Dahabreh, MD³; Atul Malhotra, MD⁴; Stefanos N. Kales, MD, MPH^1,2

Identification of Causal Genes, Networks, and Transcriptional Regulators of REM Sleep and Wake. 1469-1477.
Joshua Millstein, PhD¹; Christopher J. Winrow, PhD²; Andrew Kasarskis, PhD³; Joseph R. Owens, BE⁴; Lili Zhou, BS⁴; Keith C. Summa, BS⁴; Karrie Fitzpatrick, BS⁴; Bin Zhang, PhD¹; Martha H. Vitaterna, PhD⁴; Eric E. Schadt, PhD³; John J. Renger, PhD²; Fred W. Turek, PhD⁴

Treating Obstructive Sleep Apnea with Hypoglossal Nerve Stimulation. 1479-1486.
Peter R. Eastwood, PhD^1,2; Maree Barnes, MBBS³; Jennifer H. Walsh, PhD^1,2; Kathleen J. Maddison, BSc^1,2; Geoffrey Hee, MBBS; Alan R. Schwartz, MD⁵; Philip L. Smith, MD⁵; Atul Malhotra, MD⁶; R. Douglas McEvoy, MBBS^7,11,15; John R. Wheatley, MBBS, PhD⁸; Fergal J. O'Donoghue, MBBS, PhD^3,4; Peter D. Rochford, BAppSc, GradDip (Bio Instr)^3,9; Tom Churchward, RPSGT³; Matthew C. Campbell, MBBS³; Carsten E. Palme, MBBS¹⁰; Sam Robinson, MBBS¹¹; George S. Goding, MD¹²; Danny J. Eckert, PhD¹³; Amy S. Jordan, PhD⁴; Peter G. Catcheside, PhD^7,11,15; Louise Tyler, RN, RPSGT^8,14; Nick A. Antic, MBBS, PhD^7,11,15; Christopher J. Worsnop, MBBS, PhD^3,4; Eric J. Kezirian, MD, MPH¹⁶; David R. Hillman, MBBS¹

Sleep Duration and Sleep Quality in Relation to 12-Year Cardiovascular Disease Incidence: The MORGEN Study. 1487-1492.
Marieke P. Hoevenaar-Blom, MSc^1,2; Annemieke M.W. Spijkerman, PhD¹; Daan Kromhout, MPH, PhD²; Julia F. van den Berg, PhD³; W.M. Monique Verschuren, PhD¹

Poor Sleep Quality is Associated with Preterm Birth. 1493-1498.
Michele L. Okun, PhD¹; Christine Dunkel Schetter, PhD²; Laura M. Glynn, PhD^3,4

Poor Sleep Quality Predicts Deficient Emotion Information Processing over Time in Early Adolescence. 1499-1508.
Nirit Soffer-Dudek, PhD¹; Avi Sadeh, DSc¹; Ronald E. Dahl, MD²; Shiran Rosenblat-Stein, MA¹

The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population. 1509-1517.
Susan Redline, MD, MPH¹; Raouf Amin, MD²; Dean Beebe, PhD²; Ronald D. Chervin, MD, MS³; Susan L. Garetz, MD⁴; Bruno Giordani, PhD⁵; Carole L. Marcus, MBBCh⁶; Renee H. Moore, PhD⁷; Carol L. Rosen, MD⁸; Raanan Arens, MD⁹; David Gozal, MD¹⁰; Eliot S. Katz, MD¹¹; Ronald B. Mitchell, MD, PhD¹²; Hiren Muzumdar, MD⁹; H.G. Taylor, PhD⁸; Nina Thomas, PhD¹³; Susan Ellenberg, PhD⁷

Loneliness Is Associated with Sleep Fragmentation in a Communal Society. 1519-1526.
Lianne M. Kurina, PhD¹; Kristen L. Knutson, PhD²; Louise C. Hawkley, PhD³; John T. Cacioppo, PhD³; Diane S. Lauderdale, PhD¹; Carole Ober, PhD⁴

State-Dependent Changes in Cortical Gain Control as Measured by Auditory Evoked Responses to Varying Intensity Stimuli. 1527-1537.
Derrick J. Phillips, BS¹; Jennifer L. Schei, PhD²; Peter C. Meighan, PhD¹; David M. Rector, PhD¹

Antagonizing Corticotropin-Releasing Factor in the Central Nucleus of the Amygdala Attenuates Fear-induced Reductions in Sleep but not Freezing. 1539-1549.
Xianling Liu, MD, PhD; Laurie L. Wellman, PhD; Linghui Yang, MS; Marta A. Ambrozewicz, MD, PhD; Xiangdong Tang, MD, PhD; Larry D. Sanford, PhD

Sleep-Stage Dynamics in Patients with Chronic Fatigue Syndrome with or without Fibromyalgia. 1551-1560.
Akifumi Kishi, PhD^1,2,3; Benjamin H. Natelson, MD⁴; Fumiharu Togo, PhD⁵; Zbigniew R. Struzik, PhD¹; David M. Rapoport, MD³; Yoshiharu Yamamoto, PhD¹

Evaluation of the Association of Menopausal Status with Delta and Beta EEG Activity during Sleep. 1561-1568.
Ian G. Campbell, PhD¹; Joyce T. Bromberger, PhD^2,3; Daniel J. Buysse, MD³; Martica H. Hall, PhD³; Kimberly A. Hardin, MD⁴; Howard M. Kravitz, DO, MPH⁵; Karen A. Matthews, PhD^2,3; Marianne O'Neill Rasor, MA⁶; Jessica Utts, PhD⁷; Ellen Gold, PhD⁶

Quantification of the Fragmentation of Rest-Activity Patterns in Elderly Individuals Using a State Transition Analysis. 1569-1581.
Andrew S.P. Lim, MD¹; Lei Yu, PhD²; Madalena D. Costa, PhD^3,4; Aron S. Buchman, MD²; David A. Bennett, MD²; Sue E. Leurgans, PhD²; Clifford B. Saper, MD, PhD¹

Self-Reported Sleep Duration and Time in Bed as Predictors of Physical Function Decline: Results from the InCHIANTI Study. 1583-1593.
Sari Stenholm, PhD¹; Erkki Kronholm, PhD²; Stefania Bandinelli, MD³; Jack M. Guralnik, MD, PhD⁴; Luigi Ferrucci, MD, PhD⁵

Ethnic Disparities in CPAP Adherence in New Zealand: Effects of Socioeconomic Status, Health Literacy and Self-Efficacy. 1595-1603.
Jessie P. Bakker, PhD; Karyn M. O'Keeffe, BSc (Hons); Alister M. Neill, FRACP, MD; Angela J. Campbell, PhD

Increased Aortic Root Size is Associated with Nocturnal Hypoxia and Diastolic Blood Pressure in Obstructive Sleep Apnea. 1605-1607.
Jean-Philippe Baguet, MD, PhD^1,2; Caroline Minville, MD^3,4; Renaud Tamisier, MD, PhD^3,4; Frederic Roche, MD, PhD⁵; Gilles Barone-Rochette, MD^1,2; Olivier Ormezzano, MD, PhD^1,2; Patrick Levy, MD, PhD^3,4; Jean-Louis Pepin, MD, PhD^3,4

Erratum. 1608.
Ronald C. Kessler, PhD

 Table of Contents

Are you a subscriber?

If you are a subscriber to SLEEP (including members of the AASM and SRS), please login for full access to the journal.

Not a subscriber?

Non-subscribers have the opportunity to purchase access to individual articles for U.S. $8.00.

Click here to complete the purchase.

You may access and print any article from SLEEP for your personal scholarly, research, and educational use. Please note, access to the article is from the computer on which the article was purchased only. Purchase of the article does not permit distribution, electronic or otherwise, of the article without the written permission of APSS. Further, purchase does not permit the posting the article text on an online forum or website.

Are you a subscriber?

If you are a subscriber to SLEEP (including members of the AASM and SRS), please login for full access to the journal.

Not a subscriber?

Non-subscribers have the opportunity to purchase access to individual articles for U.S. $8.00.

Click here to complete the purchase.

You may access and print any article from SLEEP for your personal scholarly, research, and educational use. Please note, access to the article is from the computer on which the article was purchased only. Purchase of the article does not permit distribution, electronic or otherwise, of the article without the written permission of APSS. Further, purchase does not permit the posting the article text on an online forum or website.

Please wait...