Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
34 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-08-31
Study Completion Date
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A randomized single blind clinical trial, with a larger sample size than previous studies , to evaluate the effectiveness of injection snoreplasty in the treatment of patients with snoring and obstructive sleep apnea/hypopnea syndrome (OSAHS) compared to oropharyngeal exercises, a low cost therapeutic modality.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive
NCT01636856
Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).
UNKNOWN
NA
Injection Snoreplasty: Comparison Between Ethanol and Ethanolamine Oleate
NCT00804037
Snoring
Apnea
UNKNOWN
NA
Intraoral Tongue Stimulation for Treatment of Primary Snoring
NCT03829956
Snoring
Obstructive Sleep Apnea
COMPLETED
NA
LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
NCT01574768
Snore
Obstructive Sleep Apnea
UNKNOWN
NA
Assessment of OSA in Latin American and Response to Neuromod Therapy
NCT06762873
Obstructive Sleep Apnea
RECRUITING
EARLY_PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
34 patients will be randomly allocated into two groups. One group will be submitted to injection snoreplasty and another group will be submitted to daily sessions of oropharyngeal exercises. Researchers involved in interventions will not participate in the outcomes evaluation and researchers responsible for the assessment of outcomes will be blinded to the tested therapeutic modalities.
All patients will be evaluated at a pre-intervention visit, when will be collected objective data and carried out a complete otorhinolaryngological exam. Patients will fill validated specific questionnaires for evaluation of snoring, apnea, daytime sleepiness, fatigue, presence of systemic arterial hypertension and sleep quality. The quality of sleep of the patients bedroom companions will be also evaluated. Patients will be randomized only after these evaluations.
All patients included in the study will be submitted to a portable sleep study. Simultaneously, the objective assessment of snoring will be held, covering the analysis of snoring intensity (measured in decibels) and the snoring index (number of snores per hour of sleep).
Patients allocated to group A will receive injection snoreplasty. Patient returns will be weekly, until the complete healing of the palate. After four weeks of treatment, the bedroom companion will be asked about whether the snoring remains a problem, and if so, the procedure is repeated, with each patient receiving up to three applications. At the end of three months, all evaluations will be repeated and the data obtained will be compared to baseline data.
Patients allocated at group B will be evaluated by a speech therapist. Patients will undergo weekly oropharyngeal exercises sessions under supervision, lasting about 30 minutes each, and will be instructed to perform the exercises daily at home, for a period of three months. At the end of this period, patients will be re-evaluated and the initial data will be compared to the obtained final data.
All patients will be evaluated at a pre-intervention visit, when will be collected objective data and carried out a complete otorhinolaryngological exam. Patients will fill validated specific questionnaires for evaluation of snoring, apnea, daytime sleepiness, fatigue, presence of systemic arterial hypertension and sleep quality. The quality of sleep of the patients bedroom companions will be also evaluated. Patients will be randomized only after these evaluations.
All patients included in the study will be submitted to a portable sleep study. Simultaneously, the objective assessment of snoring will be held, covering the analysis of snoring intensity (measured in decibels) and the snoring index (number of snores per hour of sleep).
Patients allocated to group A will receive injection snoreplasty. Patient returns will be weekly, until the complete healing of the palate. After four weeks of treatment, the bedroom companion will be asked about whether the snoring remains a problem, and if so, the procedure is repeated, with each patient receiving up to three applications. At the end of three months, all evaluations will be repeated and the data obtained will be compared to baseline data.
Patients allocated at group B will be evaluated by a speech therapist. Patients will undergo weekly oropharyngeal exercises sessions under supervision, lasting about 30 minutes each, and will be instructed to perform the exercises daily at home, for a period of three months. At the end of this period, patients will be re-evaluated and the initial data will be compared to the obtained final data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Snoring
Obstructive Sleep Apnea Syndrome
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Injection snoreplasty
Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml of 2% xylocaine) into the upper palate. 0.5 ml of the solution will be implemented in three different regions of the submucosal layer of the soft palate, one median and two paramedians.
Group Type
ACTIVE_COMPARATOR
Injection Snoreplasty
Intervention Type
PROCEDURE
Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml of 2% xylocaine) into the upper palate.
Oropharyngeal Exercises
Weekly sessions of myofunctional exercises under the supervision of a qualified professional, lasting about 30 minutes each, combined with daily exercises without supervision for a period of three months.
Group Type
ACTIVE_COMPARATOR
Oropharyngeal Exercises
Intervention Type
OTHER
Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Injection Snoreplasty
Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml of 2% xylocaine) into the upper palate.
Intervention Type
PROCEDURE
Oropharyngeal Exercises
Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients evaluated at the Snoring and Apnea Ambulatory of Hospital de Clinicas de Porto Alegre with clinical complaints related to snoring and sleep apnea with polysomnography held within 90 days before the inclusion, evidencing index of apnea/hypopnea from 0 to 30 events per hour of sleep (snoring , mild and moderate apnea), without showing desaturation below 90% for time periods longer than 60 minutes.
* Patient without specific prior treatment for snoring and/or apnea.
* Patient without specific prior treatment for snoring and/or apnea.
Exclusion Criteria
* Prior pharyngeal surgery to treat snoring or obstructive sleep apnea/hypopnea syndrome (OSAHS).
* Body mass index above 35Kg / m2.
* Nasal or pharyngeal anatomical obstruction higher than 50% of the light.
* Craniofacial deformity.
* Pregnancy.
* Major illnesses associated.
* Ethanol allergy history.
* Absence of a companion to observe the intensity of snoring.
* Patients with no ability to understand the issues (understanding of the proposed procedure and consent form).
* Body mass index above 35Kg / m2.
* Nasal or pharyngeal anatomical obstruction higher than 50% of the light.
* Craniofacial deformity.
* Pregnancy.
* Major illnesses associated.
* Ethanol allergy history.
* Absence of a companion to observe the intensity of snoring.
* Patients with no ability to understand the issues (understanding of the proposed procedure and consent form).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital de Clinicas de Porto Alegre
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Lavinsky
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Serviço de Otorrinolaringologia do Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Brazil
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Simone C Fagondes
Role: CONTACT
55 51 3359 8000 ext. 8241
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Simone C Fagondes
Role: backup
55 51 3359-8000 ext. 8241
References
Explore related publications, articles, or registry entries linked to this study.
Siegel JM. Sleep viewed as a state of adaptive inactivity. Nat Rev Neurosci. 2009 Oct;10(10):747-53. doi: 10.1038/nrn2697. Epub 2009 Aug 5.
Reference Type
BACKGROUND
Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
Reference Type
BACKGROUND
Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220.
Reference Type
BACKGROUND
Drazen JM. Sleep apnea syndrome. N Engl J Med. 2002 Feb 7;346(6):390. doi: 10.1056/NEJM200202073460602. No abstract available.
Reference Type
BACKGROUND
Chung F, Elsaid H. Screening for obstructive sleep apnea before surgery: why is it important? Curr Opin Anaesthesiol. 2009 Jun;22(3):405-11. doi: 10.1097/ACO.0b013e32832a96e2.
Reference Type
BACKGROUND
Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
Reference Type
BACKGROUND
Vrints H, Shivalkar B, Hilde H, Vanderveken OM, Hamans E, Van de Heyning P, De Backer W, Verbraecken J. Cardiovascular mechanisms and consequences of obstructive sleep apnoea. Acta Clin Belg. 2013 May-Jun;68(3):169-78. doi: 10.2143/ACB.2981.
Reference Type
BACKGROUND
Phillipson EA. Sleep apnea--a major public health problem. N Engl J Med. 1993 Apr 29;328(17):1271-3. doi: 10.1056/NEJM199304293281712. No abstract available.
Reference Type
BACKGROUND
Ellen RL, Marshall SC, Palayew M, Molnar FJ, Wilson KG, Man-Son-Hing M. Systematic review of motor vehicle crash risk in persons with sleep apnea. J Clin Sleep Med. 2006 Apr 15;2(2):193-200.
Reference Type
BACKGROUND
Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
Reference Type
BACKGROUND
Hoffstein V, Szalai JP. Predictive value of clinical features in diagnosing obstructive sleep apnea. Sleep. 1993 Feb;16(2):118-22.
Reference Type
BACKGROUND
Zancanella E, Haddad FM, Oliveira LA, Nakasato A, Duarte BB, Soares CF, Cahali MB, Eckeli A, Caramelli B, Drager LF, Ramos BD, Nobrega M, Fagondes SC, Andrada NC; Associacao Brasileira de Otorrinolaringologia e Cirurgia Cervico-Facial; Academia Brasileira de Neurologia; Sociedade Brasileira de Cardiologia; Sociedade Brasileira de Pediatria; Sociedade Brasileira de Pneumologia e Tisiologia. Obstructive sleep apnea and primary snoring: diagnosis. Braz J Otorhinolaryngol. 2014 Jan-Feb;80(1 Suppl 1):S1-16. No abstract available. English, Portuguese.
Reference Type
BACKGROUND
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Reference Type
BACKGROUND
Koskenvuo M, Kaprio J, Telakivi T, Partinen M, Heikkila K, Sarna S. Snoring as a risk factor for ischaemic heart disease and stroke in men. Br Med J (Clin Res Ed). 1987 Jan 3;294(6563):16-9. doi: 10.1136/bmj.294.6563.16.
Reference Type
BACKGROUND
Schmidt-Nowara WW, Coultas DB, Wiggins C, Skipper BE, Samet JM. Snoring in a Hispanic-American population. Risk factors and association with hypertension and other morbidity. Arch Intern Med. 1990 Mar;150(3):597-601. doi: 10.1001/archinte.150.3.597.
Reference Type
BACKGROUND
Norton PG, Dunn EV. Snoring as a risk factor for disease: an epidemiological survey. Br Med J (Clin Res Ed). 1985 Sep 7;291(6496):630-2. doi: 10.1136/bmj.291.6496.630.
Reference Type
BACKGROUND
Hoffstein V. Blood pressure, snoring, obesity, and nocturnal hypoxaemia. Lancet. 1994 Sep 3;344(8923):643-5. doi: 10.1016/s0140-6736(94)92084-2.
Reference Type
BACKGROUND
Yeboah J, Redline S, Johnson C, Tracy R, Ouyang P, Blumenthal RS, Burke GL, Herrington DM. Association between sleep apnea, snoring, incident cardiovascular events and all-cause mortality in an adult population: MESA. Atherosclerosis. 2011 Dec;219(2):963-8. doi: 10.1016/j.atherosclerosis.2011.08.021. Epub 2011 Aug 22.
Reference Type
BACKGROUND
Marshall NS, Wong KK, Cullen SR, Knuiman MW, Grunstein RR. Snoring is not associated with all-cause mortality, incident cardiovascular disease, or stroke in the Busselton Health Study. Sleep. 2012 Sep 1;35(9):1235-40. doi: 10.5665/sleep.2076.
Reference Type
BACKGROUND
Lee SA, Amis TC, Byth K, Larcos G, Kairaitis K, Robinson TD, Wheatley JR. Heavy snoring as a cause of carotid artery atherosclerosis. Sleep. 2008 Sep;31(9):1207-13.
Reference Type
BACKGROUND
Beninati W, Harris CD, Herold DL, Shepard JW Jr. The effect of snoring and obstructive sleep apnea on the sleep quality of bed partners. Mayo Clin Proc. 1999 Oct;74(10):955-8. doi: 10.4065/74.10.955.
Reference Type
BACKGROUND
Collop NA. Portable monitoring for the diagnosis of obstructive sleep apnea. Curr Opin Pulm Med. 2008 Nov;14(6):525-9. doi: 10.1097/MCP.0b013e328312ed4a.
Reference Type
BACKGROUND
Brietzke SE, Mair EA. Injection snoreplasty: how to treat snoring without all the pain and expense. Otolaryngol Head Neck Surg. 2001 May;124(5):503-10. doi: 10.1067/mhn.2001.115400.
Reference Type
BACKGROUND
Schwab RJ, Pasirstein M, Pierson R, Mackley A, Hachadoorian R, Arens R, Maislin G, Pack AI. Identification of upper airway anatomic risk factors for obstructive sleep apnea with volumetric magnetic resonance imaging. Am J Respir Crit Care Med. 2003 Sep 1;168(5):522-30. doi: 10.1164/rccm.200208-866OC. Epub 2003 May 13.
Reference Type
BACKGROUND
Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. doi: 10.1093/sleep/19.2.156.
Reference Type
BACKGROUND
Nordgard S, Stene BK, Skjostad KW. Soft palate implants for the treatment of mild to moderate obstructive sleep apnea. Otolaryngol Head Neck Surg. 2006 Apr;134(4):565-70. doi: 10.1016/j.otohns.2005.11.034.
Reference Type
BACKGROUND
Friedman M, Schalch P, Lin HC, Kakodkar KA, Joseph NJ, Mazloom N. Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2008 Feb;138(2):209-16. doi: 10.1016/j.otohns.2007.10.026.
Reference Type
BACKGROUND
Powell NB, Riley RW, Troell RJ, Li K, Blumen MB, Guilleminault C. Radiofrequency volumetric tissue reduction of the palate in subjects with sleep-disordered breathing. Chest. 1998 May;113(5):1163-74. doi: 10.1378/chest.113.5.1163.
Reference Type
BACKGROUND
Gunawardena I, Robinson S, MacKay S, Woods CM, Choo J, Esterman A, Carney AS. Submucosal lingualplasty for adult obstructive sleep apnea. Otolaryngol Head Neck Surg. 2013 Jan;148(1):157-65. doi: 10.1177/0194599812461750. Epub 2012 Sep 26.
Reference Type
BACKGROUND
Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.
Reference Type
BACKGROUND
STRAUSS JF. A new approach to the treatment of snoring: A preliminary report. Arch Otolaryngol.1943 Sep;38(3):225-9.
Reference Type
BACKGROUND
Brietzke SE, Mair EA. Injection snoreplasty: extended follow-up and new objective data. Otolaryngol Head Neck Surg. 2003 May;128(5):605-15. doi: 10.1016/S0194-59980300229-8.
Reference Type
BACKGROUND
Iseri M, Balcioglu O. Radiofrequency versus injection snoreplasty in simple snoring. Otolaryngol Head Neck Surg. 2005 Aug;133(2):224-8. doi: 10.1016/j.otohns.2005.04.018.
Reference Type
BACKGROUND
Al-Jassim AH, Lesser TH. Single dose injection snoreplasty: investigation or treatment? J Laryngol Otol. 2008 Nov;122(11):1190-3. doi: 10.1017/S0022215108002648. Epub 2008 Jun 9.
Reference Type
BACKGROUND
Lorenzetti FTM. Injeção roncoplástica: comparação entre etanol 50% e oleato de etanolamina 5% no tratamento do ronco [Internet] [text]. Universidade de São Paulo; 2011. At http://www.teses.usp.br/teses/disponiveis/5/5143/tde-20072011-151743/
Reference Type
BACKGROUND
Labra A, Haro-Valencia R, Huerta-Delgado AD, Jimenez-Correa U, Sanchez-Narvaez F. Efficacy of submucosal sodium tetradecyl sulfate in the soft palate as a treatment of the mild obstructive sleep apnea syndrome: a pilot study. Sleep Disord. 2012;2012:597684. doi: 10.1155/2012/597684. Epub 2012 Jan 24.
Reference Type
BACKGROUND
Puhan MA, Suarez A, Lo Cascio C, Zahn A, Heitz M, Braendli O. Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial. BMJ. 2006 Feb 4;332(7536):266-70. doi: 10.1136/bmj.38705.470590.55. Epub 2005 Dec 23.
Reference Type
BACKGROUND
Guimarães KCC. Efeitos dos exercícios orofaríngeos em pacientes com apnéia obstrutiva do sono moderada: estudo controlado e randomizado [Internet] [text]. Universidade de São Paulo; 2008. At: http://www.teses.usp.br/teses/disponiveis/5/5150/tde-22082008-170703/
Reference Type
BACKGROUND
Friedman M, Ibrahim H, Joseph NJ. Staging of obstructive sleep apnea/hypopnea syndrome: a guide to appropriate treatment. Laryngoscope. 2004 Mar;114(3):454-9. doi: 10.1097/00005537-200403000-00013.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-0637
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Oropharyngeal Exercises to Treat Obstructive Sleep Apnea
NCT05678088
RECRUITING
NA
Pharmacological Intervention for Symptomatic Snoring
NCT03720353
COMPLETED
PHASE1/PHASE2
Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring and Mild Sleep Apnoea
NCT04392765
UNKNOWN
NA
Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
NCT01289405
COMPLETED
NA
Validation of a Snoring App Against Commercially Available Applications and PSG
NCT07097597
NOT_YET_RECRUITING
Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
NCT01336556
UNKNOWN
NA
Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea
NCT02834767
COMPLETED
NA
The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep
NCT03506178
UNKNOWN
NA
Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study
NCT02952118
UNKNOWN
NA
New Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome
NCT05206916
UNKNOWN
NA
Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea
NCT00660777
COMPLETED
PHASE3
Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring
NCT05643352
UNKNOWN
NA
Comprehensive Management for the Treatment of Obstructive Sleep Apnea
NCT02482480
COMPLETED
NA
OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA
NCT06681974
RECRUITING
PHASE3
Clinical Tial of Er:YAG Laser Snoring Treatment
NCT03947424
UNKNOWN
NA
Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure
NCT06999746
NOT_YET_RECRUITING
NA
Upper Airway Training for Treatment of Snoring
NCT03264963
COMPLETED
NA
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
NCT01265121
UNKNOWN
NA
Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
NCT06103630
RECRUITING
NA
Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP
NCT05432908
TERMINATED
NA
Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS)
NCT02695667
TERMINATED
Effects of Exercise Training on Cognitive Performance and Sympathetic Activity in Obstructive Sleep Apnea
NCT02289625
UNKNOWN
NA
A Post-marketing Surveillance of the Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
NCT02698059
UNKNOWN
NA
Upper Airway Obstruction in Non-obese Patients With Snoring and Obstructive Sleep Apnea
NCT04324671
UNKNOWN
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
NCT02324790
TERMINATED
NA