Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-06 @ 1:08 PM
Study NCT ID:
NCT03517150
Status:
UNKNOWN
Last Update Posted:
2018-05-21
First Post:
2018-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017090', 'term': 'Occlusal Splints'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '10 minutes', 'description': 'The Short-Form 36-Item Health Survey (SF-36) will be used to measure quality of life. This instrument will evaluate the physical health component (PHC) and the mental health component (MHC) through the following dimensions: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health.'}, {'measure': 'Daytime sleepiness', 'timeFrame': '5 minutes', 'description': 'The Epworth sleepiness scale (ESS) wil measure the subjective daytime sleepiness, assesses the propensity to sleep under inappropriate circumstances. The ESS questionnaire consists of 8 questions about daytime sleepiness in various situations.'}, {'measure': 'Quality of sleep', 'timeFrame': '5 minutes', 'description': 'The Pittsburgh Sleep Quality Index is the instrument deployed to evaluate the subjective quality of sleep and the presence of possible disorders. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The score is determined by the sum of the seven components, with each answer being given a score between 0 and 3 points. The maximum score of the instrument is 21. The scores\\> 5 points indicate poor quality in the sleep pattern.'}], 'secondaryOutcomes': [{'measure': 'Apnea-hypopnea index (AHI)', 'timeFrame': '8 hours', 'description': 'The obstructive Apnea-hypopnea Index is defined as the mean number of obstructive apneas and hypopneas per hour of sleep, thus: the occurrence of 5 to 14 events per hour of sleep means presence of mild apnea, 15 to 29 moderate apnea and ≥ 30 severe apnea. The AHI is derived from overnight polysomnography.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '19231343', 'type': 'BACKGROUND', 'citation': 'Takama N, Kurabayashi M. Influence of untreated sleep-disordered breathing on the long-term prognosis of patients with cardiovascular disease. Am J Cardiol. 2009 Mar 1;103(5):730-4. doi: 10.1016/j.amjcard.2008.10.035. Epub 2009 Jan 12.'}, {'pmid': '23280227', 'type': 'BACKGROUND', 'citation': 'Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.'}, {'pmid': '19238814', 'type': 'BACKGROUND', 'citation': 'Hamilton GS, Meredith IT, Walker AM, Solin P. Obstructive sleep apnea leads to transient uncoupling of coronary blood flow and myocardial work in humans. Sleep. 2009 Feb;32(2):263-70. doi: 10.1093/sleep/32.2.263.'}, {'pmid': '24570244', 'type': 'BACKGROUND', 'citation': 'Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.'}, {'pmid': '19299006', 'type': 'BACKGROUND', 'citation': 'Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.'}, {'pmid': '22269499', 'type': 'BACKGROUND', 'citation': 'Tefft BC. Prevalence of motor vehicle crashes involving drowsy drivers, United States, 1999-2008. Accid Anal Prev. 2012 Mar;45:180-6. doi: 10.1016/j.aap.2011.05.028.'}, {'pmid': '29554902', 'type': 'BACKGROUND', 'citation': 'Gottlieb DJ, Ellenbogen JM, Bianchi MT, Czeisler CA. Sleep deficiency and motor vehicle crash risk in the general population: a prospective cohort study. BMC Med. 2018 Mar 20;16(1):44. doi: 10.1186/s12916-018-1025-7.'}, {'pmid': '25129165', 'type': 'BACKGROUND', 'citation': 'Jurado-Gamez B, Guglielmi O, Gude F, Buela-Casal G. Workplace accidents, absenteeism and productivity in patients with sleep apnea. Arch Bronconeumol. 2015 May;51(5):213-8. doi: 10.1016/j.arbres.2014.07.003. Epub 2014 Aug 13. English, Spanish.'}, {'pmid': '24952614', 'type': 'BACKGROUND', 'citation': 'Guglielmi O, Jurado-Gamez B, Gude F, Buela-Casal G. Occupational health of patients with obstructive sleep apnea syndrome: a systematic review. Sleep Breath. 2015 Mar;19(1):35-44. doi: 10.1007/s11325-014-1015-8. Epub 2014 Jun 22.'}, {'pmid': '26039963', 'type': 'BACKGROUND', 'citation': 'Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. 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Epub 2016 Oct 31.'}, {'pmid': '15602591', 'type': 'BACKGROUND', 'citation': 'Taheri S, Lin L, Austin D, Young T, Mignot E. Short sleep duration is associated with reduced leptin, elevated ghrelin, and increased body mass index. PLoS Med. 2004 Dec;1(3):e62. doi: 10.1371/journal.pmed.0010062. Epub 2004 Dec 7.'}, {'pmid': '16505522', 'type': 'BACKGROUND', 'citation': 'Yaggi HK, Araujo AB, McKinlay JB. Sleep duration as a risk factor for the development of type 2 diabetes. Diabetes Care. 2006 Mar;29(3):657-61. doi: 10.2337/diacare.29.03.06.dc05-0879.'}, {'pmid': '24736037', 'type': 'BACKGROUND', 'citation': 'Cowan DC, Allardice G, Macfarlane D, Ramsay D, Ambler H, Banham S, Livingston E, Carlin C. Predicting sleep disordered breathing in outpatients with suspected OSA. BMJ Open. 2014 Apr 15;4(4):e004519. doi: 10.1136/bmjopen-2013-004519.'}, {'pmid': '28876375', 'type': 'BACKGROUND', 'citation': 'Correa CM, Gismondi RA, Cunha AR, Neves MF, Oigman W. Twenty-four hour Blood Pressure in Obese Patients with Moderate-to-Severe Obstructive Sleep Apnea. Arq Bras Cardiol. 2017 Oct;109(4):313-320. doi: 10.5935/abc.20170130. Epub 2017 Sep 4.'}, {'pmid': '18807673', 'type': 'BACKGROUND', 'citation': 'Lopez PP, Stefan B, Schulman CI, Byers PM. Prevalence of sleep apnea in morbidly obese patients who presented for weight loss surgery evaluation: more evidence for routine screening for obstructive sleep apnea before weight loss surgery. Am Surg. 2008 Sep;74(9):834-8.'}, {'pmid': '24179297', 'type': 'BACKGROUND', 'citation': 'Bartlett D, Wong K, Richards D, Moy E, Espie CA, Cistulli PA, Grunstein R. Increasing adherence to obstructive sleep apnea treatment with a group social cognitive therapy treatment intervention: a randomized trial. Sleep. 2013 Nov 1;36(11):1647-54. doi: 10.5665/sleep.3118.'}, {'pmid': '26094920', 'type': 'BACKGROUND', 'citation': 'Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.'}, {'pmid': '28050420', 'type': 'BACKGROUND', 'citation': 'Battan G, Kumar S, Panwar A, Atam V, Kumar P, Gangwar A, Roy U. Effect of CPAP Therapy in Improving Daytime Sleepiness in Indian Patients with Moderate and Severe OSA. J Clin Diagn Res. 2016 Nov;10(11):OC14-OC16. doi: 10.7860/JCDR/2016/23800.8876. Epub 2016 Nov 1.'}, {'pmid': '23997361', 'type': 'BACKGROUND', 'citation': 'Doff MH, Hoekema A, Wijkstra PJ, van der Hoeven JH, Huddleston Slater JJ, de Bont LG, Stegenga B. Oral appliance versus continuous positive airway pressure in obstructive sleep apnea syndrome: a 2-year follow-up. Sleep. 2013 Sep 1;36(9):1289-96. doi: 10.5665/sleep.2948.'}, {'pmid': '24957654', 'type': 'BACKGROUND', 'citation': 'Young D, Collop N. Advances in the treatment of obstructive sleep apnea. 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Effects of CPAP and Mandibular Advancement Devices on Health-Related Quality of Life in OSA: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):786-794. doi: 10.1016/j.chest.2017.01.020. Epub 2017 Jan 24.'}, {'pmid': '29129030', 'type': 'BACKGROUND', 'citation': 'Schwartz M, Acosta L, Hung YL, Padilla M, Enciso R. Effects of CPAP and mandibular advancement device treatment in obstructive sleep apnea patients: a systematic review and meta-analysis. Sleep Breath. 2018 Sep;22(3):555-568. doi: 10.1007/s11325-017-1590-6. Epub 2017 Nov 11.'}, {'type': 'BACKGROUND', 'citation': 'Sutherland K, Phillips CL, Cistulli PA (2015) Efficacy versus effectiveness in the treatment of obstructive sleep apnea: CPAP and oralappliances.J Dent Sleep Med2:175-181.10.15331/jdsm.5120'}, {'pmid': '25207802', 'type': 'BACKGROUND', 'citation': 'Haviv Y, Bachar G, Aframian DJ, Almoznino G, Michaeli E, Benoliel R. A 2-year mean follow-up of oral appliance therapy for severe obstructive sleep apnea: a cohort study. Oral Dis. 2015 Apr;21(3):386-92. doi: 10.1111/odi.12291. Epub 2014 Oct 28.'}, {'pmid': '17136406', 'type': 'BACKGROUND', 'citation': 'Hoffstein V. Review of oral appliances for treatment of sleep-disordered breathing. Sleep Breath. 2007 Mar;11(1):1-22. doi: 10.1007/s11325-006-0084-8.'}, {'pmid': '18066623', 'type': 'RESULT', 'citation': 'AlGhanim N, Comondore VR, Fleetham J, Marra CA, Ayas NT. The economic impact of obstructive sleep apnea. Lung. 2008 Jan-Feb;186(1):7-12. doi: 10.1007/s00408-007-9055-5. Epub 2007 Dec 8.'}, {'pmid': '22374151', 'type': 'RESULT', 'citation': 'Anandam A, Akinnusi M, Kufel T, Porhomayon J, El-Solh AA. Effects of dietary weight loss on obstructive sleep apnea: a meta-analysis. Sleep Breath. 2013 Mar;17(1):227-34. doi: 10.1007/s11325-012-0677-3. Epub 2012 Feb 29.'}, {'pmid': '23066376', 'type': 'RESULT', 'citation': 'Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.'}], 'seeAlsoLinks': [{'url': 'http://www.aasmnet.org/store/product.aspx?pid=10', 'label': 'American Academy of Sleep Medicine'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of intraoral appliance in the treatment of obstructive sleep Apnea Syndrome in class III obese in comparison to an adjustable silicone appliance. Both treatments will be test by all of the participants and they will make the polysomnography exam to have the outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥40 kg/m² and ≤ 49,9 kg/m²\n* Female and male patients (Both of gender patients) with ages between 20 to 65 years old\n* Obstructive Sleep Apnea (OSA) diagnosis by polysomnography\n\nExclusion Criteria:\n\n* sedative drugs users\n* Oxygen-dependent or decompensated lung disease\n* Decompensated congestive heart failure\n* Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia)\n* craniofacial deformities carriers\n* previous OSAS Diagnosis and treatment\n* Active Oncological diseases in the last ten years\n* Patients with less than 8 teeth per arcade;\n* Patients with advanced periodontitis;'}, 'identificationModule': {'nctId': 'NCT03517150', 'briefTitle': 'Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III', 'orgStudyIdInfo': {'id': 'FOB apnea'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'This group will use an oral appliance for treatment of obstructive sleep apnea. The oral appliance is custom-made and its titration is attained by means of progressive mandibular advancement that incrementally moves the mandible forward. This group of patients will use the oral appliance for 45 days.', 'interventionNames': ['Device: mandibular advancement device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'This group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group.', 'interventionNames': ['Device: mandibular advancement device']}], 'interventions': [{'name': 'mandibular advancement device', 'type': 'DEVICE', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Silvia de Carvalho Alvarenga', 'investigatorAffiliation': 'University of Sao Paulo'}}}}