Sleep Apnea, Obstructive Clinical Trial
Official title:
Caliber of Upper Airway Measured by Acoustic Pharyngometry in Children With Obstructive Sleep Apnea Before and After the Use of Presurgical CPAP and After Adentonsillectomy, and Their Relation With Surgical Complications and Residual Apneas
NCT number | NCT03169491 |
Other study ID # | C12-16 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 4, 2016 |
Est. completion date | November 30, 2019 |
Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe complications, and its first line of treatment (adenotonsillectomy) has risk of complications. Even though the use of presurgical CPAP seems logical due to its effects in adults, it must be studied in children due to the different physiopathology and adherence. One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the anatomical site of obstruction. The post-surgical anatomical changes could correlate with a persistent OSAS, which would be helpful in selecting those patients who require a post surgical sleep study. The main goal of the study is to cuantify the changes in the oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after adentonsillectomy in children.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | November 30, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Age between 4 and 14 years old. Both genders. Diagnosis of OSAS based on sleep study (respiratory polygraphy or polysomnography). Surgical treatment planned by the ORL department of the Institute of Respiratory Diseases of Mexico. Residents of the Metropolitan Area of Mexico City Parents and child accept to particpate in the study, singning informed consent and assent. Exclusion Criteria: - Previous surgery in upper airway. Craneofacial malformation. Previous use of CPAP. Syndromatic patient. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional Enfermedades Respiratorias | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Enfermedades Respiratorias |
Mexico,
Castorena-Maldonado A, Torre-Bouscoulet L, Meza-Vargas S, Vázquez-García JC, López-Escárcega E, Pérez-Padilla R. Preoperative continuous positive airway pressure compliance in children with obstructive sleep apnea syndrome: assessed by a simplified approach. Int J Pediatr Otorhinolaryngol. 2008 Dec;72(12):1795-800. doi: 10.1016/j.ijporl.2008.08.016. Epub 2008 Oct 4. — View Citation
Corda L, Redolfi S, Montemurro LT, La Piana GE, Bertella E, Tantucci C. Short- and long-term effects of CPAP on upper airway anatomy and collapsibility in OSAH. Sleep Breath. 2009 May;13(2):187-93. doi: 10.1007/s11325-008-0219-1. Epub 2008 Sep 25. — View Citation
De Luca Canto G, Pachêco-Pereira C, Aydinoz S, Bhattacharjee R, Tan HL, Kheirandish-Gozal L, Flores-Mir C, Gozal D. Adenotonsillectomy Complications: A Meta-analysis. Pediatrics. 2015 Oct;136(4):702-18. doi: 10.1542/peds.2015-1283. Epub 2015 Sep 21. Review. — View Citation
Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5. Review. — View Citation
Kang KT, Hsu WC. Adenotonsillectomy outcomes in treatment of obstructive sleep apnea in children: a multicenter retrospective study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):927; author reply 927-8. — View Citation
Monahan KJ, Larkin EK, Rosen CL, Graham G, Redline S. Utility of noninvasive pharyngometry in epidemiologic studies of childhood sleep-disordered breathing. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1499-503. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Residual respiratory disturbance index. | Number of events of apnea, hypopnea per hour as measured by type 3 sleep monitor. | Three months after adenotonsillectomy. | |
Primary | Oropharyngeal volume postCPAP. | Upper airway volume as measured by acoustic pharyngometry. | After two weeks of CPAP use. | |
Secondary | Oropharyngeal volume post-surgery | Upper airway volume as measured by acoustic pharyngometry. | Three months after adenotonsillectomy. | |
Secondary | OSA-18. | Score in que quality of life questionnaire OSA-18. | After two weeks of CPAP use. | |
Secondary | OSA-18. | Score in que quality of life questionnaire OSA-18. | Three months after adenotonsillectomy. | |
Secondary | Pediatric Sleep Questionnaire. | Symptoms as described in the pediatric sleep questionnaire. | After two weeks of CPAP use. | |
Secondary | Pediatric Sleep Questionnaire. | Symptoms as described in the pediatric sleep questionnaire. | Three months after adentonsillectomy. | |
Secondary | Surgical complications. | Complications during or after the surgical procedure, as determined by checklist. | During and one month after surgery. |
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