<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427111</url>
  </required_header>
  <id_info>
    <org_study_id>2015-KAEK-84</org_study_id>
    <nct_id>NCT04427111</nct_id>
  </id_info>
  <brief_title>Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter</brief_title>
  <official_title>Therapeutic Efficiency Analyses of Mandibular Advancement Devices on Obstructive Sleep Apnea Using Polysomnography, Smartphone Sleep Applications, and Simple Pulse Oximeter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bahadır EZMEK</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational clinical trial in a single centre. The objective of this study was to&#xD;
      determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity,&#xD;
      frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA)&#xD;
      patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10&#xD;
      males) with subjective snoring complaint were selected. Each patient's diagnostic&#xD;
      polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was&#xD;
      subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different&#xD;
      nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO),&#xD;
      snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using&#xD;
      SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular&#xD;
      protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO&#xD;
      and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment&#xD;
      process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA&#xD;
      values were compared with initial diagnostic values.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 24, 2015</start_date>
  <completion_date type="Actual">December 24, 2017</completion_date>
  <primary_completion_date type="Actual">December 24, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months</measure>
    <time_frame>at baseline and in 6 months</time_frame>
    <description>AHI was defined as total number of apnea or hypopnea events which lasts for at least ten seconds per hour during full nigth polysomnography (PSG) and accepted to be the main physiological sleep parameter in the present study. The AHI values were used for the evaluation of the severity of OSA and the MAD's treatment success in OSA patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen-desaturation index (ODI)</measure>
    <time_frame>at baseline and in 6 months</time_frame>
    <description>ODI was used to evaluate the desaturation fluctuations during full night PSG. ODI is defined as 3-4% decrease in oxygen saturation per hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Snoring index (SI)</measure>
    <time_frame>at baseline and in 6 months</time_frame>
    <description>SI was used to evaluate snoring events per hour during PSG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple pulse oximeter (SPO)/ODI</measure>
    <time_frame>at baseline and 1, 4, 12, and 24 week of MAD treatment</time_frame>
    <description>SPO/ODI was used to evaluate the desaturation fluctuations during sleep in-home environment by using simple pulse oximeter device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smartphone sleep application (SSA)/snoring intensity score (SIS)</measure>
    <time_frame>at baseline and 1, 4, 12, and 24 week of MAD treatment</time_frame>
    <description>SSA/SIS was used to evaluate snoring intensity that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SIS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SSA/snoring percentage (SP)</measure>
    <time_frame>at baseline and 1, 4, 12, and 24 week of MAD treatment</time_frame>
    <description>SSA/SP was the ratio of total snoring time to total sleep time that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SP.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Mild-moderate OSA patients for MAD treatment</arm_group_label>
    <description>Patients are classified as mild Obstructive Sleep Apnea (OSA) if they have between 5-15 Apnea-Hypopnea Index, moderate if they have between 15-30, and severe if they have &gt;30, as measured by Polysomnography (Epstein LJ, Kristo D, Strollo PJ, et al. 2009). The principal treatment methodology for OSA patients is positive airway pressure. In patients with mild to moderate OSA, oral appliances such as mandibular advancement devices (MAD) is alternately indicated (Ramar K, Dort LC, Katz SG, et al. 2015) The American Academy of Dental Sleep Medicine (Ramar K, Dort LC, Katz SG, et al. 2015) recommended titratable-customized MADs for patient comfort and the ability to permit modifications in the amount of mandibular protrusion for treatment efficacy. However, Aarab et al (Aarab G, Lobbezoo F, Hamburger HL, Naeije M. 2010) demonstrated similar therapeutic efficiency of non-titratable-customized MADs in the treatment of OSA</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-titratable-customized mandibular advancement device</intervention_name>
    <description>The most comfortable protruded mandibular position situated between 60-75% of MMPV was determined according to patient response with 6mm of the vertical interocclusal dimension between maxillary and mandibular central incisors and registered. The upper and lower acrylic resin splints were secured to each other in the posterior region with auto polymerizing acrylic resin and NTC-MADs were obtained. The patients were instructed to wear their non-titratable-customized mandibular advancement device every night.</description>
    <arm_group_label>Mild-moderate OSA patients for MAD treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mild-moderate obstructive sleep apnea patients were referred Department of Prosthodontics,&#xD;
        Gülhane Faculty of Dentistry for oral appliance treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild-moderate OSA patients with subjective snoring complaints&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe OSA&#xD;
&#xD;
          -  Undergone previous surgical therapy for SS or OSA&#xD;
&#xD;
          -  High-risk of cardiovascular, respiratory, neurological, or psychiatric disorders&#xD;
&#xD;
          -  Inadequate dental anchor for MAD treatment&#xD;
&#xD;
          -  Temporomandibular joint dysfunction&#xD;
&#xD;
          -  Angle Class III maxillomandibular relation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bulent Piskin, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Technology of Dental Prosthodontics, Kapadokya University, Turkey</affiliation>
  </overall_official>
  <results_reference>
    <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.</citation>
    <PMID>26094920</PMID>
  </results_reference>
  <results_reference>
    <citation>Aarab G, Lobbezoo F, Hamburger HL, Naeije M. Effects of an oral appliance with different mandibular protrusion positions at a constant vertical dimension on obstructive sleep apnea. Clin Oral Investig. 2010 Jun;14(3):339-45. doi: 10.1007/s00784-009-0298-9. Epub 2009 Jun 18.</citation>
    <PMID>19536571</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhou J, Liu YH. A randomised titrated crossover study comparing two oral appliances in the treatment for mild to moderate obstructive sleep apnoea/hypopnoea syndrome. J Oral Rehabil. 2012 Dec;39(12):914-22. doi: 10.1111/joor.12006. Epub 2012 Sep 27.</citation>
    <PMID>23016888</PMID>
  </results_reference>
  <results_reference>
    <citation>Fiz JA, Jane R, Sola-Soler J, Abad J, Garcia MA, Morera J. Continuous analysis and monitoring of snores and their relationship to the apnea-hypopnea index. Laryngoscope. 2010 Apr;120(4):854-62. doi: 10.1002/lary.20815.</citation>
    <PMID>20222022</PMID>
  </results_reference>
  <results_reference>
    <citation>Umemoto G, Toyoshima H, Yamaguchi Y, Aoyagi N, Yoshimura C, Funakoshi K. Therapeutic Efficacy of Twin-Block and Fixed Oral Appliances in Patients with Obstructive Sleep Apnea Syndrome. J Prosthodont. 2019 Feb;28(2):e830-e836. doi: 10.1111/jopr.12619. Epub 2017 Apr 19.</citation>
    <PMID>28422345</PMID>
  </results_reference>
  <results_reference>
    <citation>Isacsson G, Fodor C, Sturebrand M. Obstructive sleep apnea treated with custom-made bibloc and monobloc oral appliances: a retrospective comparative study. Sleep Breath. 2017 Mar;21(1):93-100. doi: 10.1007/s11325-016-1377-1. Epub 2016 Jul 5.</citation>
    <PMID>27380034</PMID>
  </results_reference>
  <results_reference>
    <citation>Jobin V, Mayer P, Bellemare F. Predictive value of automated oxygen saturation analysis for the diagnosis and treatment of obstructive sleep apnoea in a home-based setting. Thorax. 2007 May;62(5):422-7. doi: 10.1136/thx.2006.061234. Epub 2007 Jan 24.</citation>
    <PMID>17251319</PMID>
  </results_reference>
  <results_reference>
    <citation>Ernst G, Bosio M, Salvado A, Dibur E, Nigro C, Borsini E. Difference between apnea-hypopnea index (AHI) and oxygen desaturation index (ODI): proportional increase associated with degree of obesity. Sleep Breath. 2016 Dec;20(4):1175-1183. doi: 10.1007/s11325-016-1330-3. Epub 2016 Mar 30.</citation>
    <PMID>27026417</PMID>
  </results_reference>
  <results_reference>
    <citation>Camacho M, Robertson M, Abdullatif J, Certal V, Kram YA, Ruoff CM, Brietzke SE, Capasso R. Smartphone apps for snoring. J Laryngol Otol. 2015 Oct;129(10):974-9. doi: 10.1017/S0022215115001978. Epub 2015 Sep 3.</citation>
    <PMID>26333720</PMID>
  </results_reference>
  <results_reference>
    <citation>Stippig A, Hubers U, Emerich M. Apps in sleep medicine. Sleep Breath. 2015 Mar;19(1):411-7. doi: 10.1007/s11325-014-1009-6. Epub 2014 Jun 3.</citation>
    <PMID>24888483</PMID>
  </results_reference>
  <results_reference>
    <citation>Walker-Engstrom ML, Ringqvist I, Vestling O, Wilhelmsson B, Tegelberg A. A prospective randomized study comparing two different degrees of mandibular advancement with a dental appliance in treatment of severe obstructive sleep apnea. Sleep Breath. 2003 Sep;7(3):119-30. doi: 10.1007/s11325-003-0119-3.</citation>
    <PMID>14569523</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee CH, Mo JH, Choi IJ, Lee HJ, Seo BS, Kim DY, Yun PY, Yoon IY, Won Lee H, Kim JW. The mandibular advancement device and patient selection in the treatment of obstructive sleep apnea. Arch Otolaryngol Head Neck Surg. 2009 May;135(5):439-44. doi: 10.1001/archoto.2009.31.</citation>
    <PMID>19451462</PMID>
  </results_reference>
  <results_reference>
    <citation>Petri N, Svanholt P, Solow B, Wildschiodtz G, Winkel P. Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design. J Sleep Res. 2008 Jun;17(2):221-9. doi: 10.1111/j.1365-2869.2008.00645.x.</citation>
    <PMID>18482111</PMID>
  </results_reference>
  <results_reference>
    <citation>Nerfeldt P, Friberg D. Effectiveness of Oral Appliances in Obstructive Sleep Apnea with Respiratory Arousals. J Clin Sleep Med. 2016 Aug 15;12(8):1159-65. doi: 10.5664/jcsm.6058.</citation>
    <PMID>27397661</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</investigator_affiliation>
    <investigator_full_name>Bahadır EZMEK</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Snoring</keyword>
  <keyword>Obstructive sleep apnea</keyword>
  <keyword>Mandibular advancement device</keyword>
  <keyword>Pulse oximeter device</keyword>
  <keyword>Smartphone sleep applications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427111
org study id: 2015-KAEK-84
nct id: NCT04427111
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
An observational clinical trial in a single centre. The objective of this study was to
      determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity,
      frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA)
      patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10
      males) with subjective snoring complaint were selected. Each patient's diagnostic
      polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was
      subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different
      nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO),
      snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using
      SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular
      protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO
      and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment
      process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA
      values were compared with initial diagnostic values.
observational model: Case-Only
time perspective: Prospective
measure: Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months
time frame: at baseline and in 6 months
description: AHI was defined as total number of apnea or hypopnea events which lasts for at least ten seconds per hour during full nigth polysomnography (PSG) and accepted to be the main physiological sleep parameter in the present study. The AHI values were used for the evaluation of the severity of OSA and the MAD's treatment success in OSA patients
measure: Oxygen-desaturation index (ODI)
time frame: at baseline and in 6 months
description: ODI was used to evaluate the desaturation fluctuations during full night PSG. ODI is defined as 3-4% decrease in oxygen saturation per hour.
measure: Snoring index (SI)
time frame: at baseline and in 6 months
description: SI was used to evaluate snoring events per hour during PSG
measure: Simple pulse oximeter (SPO)/ODI
time frame: at baseline and 1, 4, 12, and 24 week of MAD treatment
description: SPO/ODI was used to evaluate the desaturation fluctuations during sleep in-home environment by using simple pulse oximeter device
measure: Smartphone sleep application (SSA)/snoring intensity score (SIS)
time frame: at baseline and 1, 4, 12, and 24 week of MAD treatment
description: SSA/SIS was used to evaluate snoring intensity that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SIS
measure: SSA/snoring percentage (SP)
time frame: at baseline and 1, 4, 12, and 24 week of MAD treatment
description: SSA/SP was the ratio of total snoring time to total sleep time that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SP.
arm group label: Mild-moderate OSA patients for MAD treatment
description: Patients are classified as mild Obstructive Sleep Apnea (OSA) if they have between 5-15 Apnea-Hypopnea Index, moderate if they have between 15-30, and severe if they have >30, as measured by Polysomnography (Epstein LJ, Kristo D, Strollo PJ, et al. 2009). The principal treatment methodology for OSA patients is positive airway pressure. In patients with mild to moderate OSA, oral appliances such as mandibular advancement devices (MAD) is alternately indicated (Ramar K, Dort LC, Katz SG, et al. 2015) The American Academy of Dental Sleep Medicine (Ramar K, Dort LC, Katz SG, et al. 2015) recommended titratable-customized MADs for patient comfort and the ability to permit modifications in the amount of mandibular protrusion for treatment efficacy. However, Aarab et al (Aarab G, Lobbezoo F, Hamburger HL, Naeije M. 2010) demonstrated similar therapeutic efficiency of non-titratable-customized MADs in the treatment of OSA
intervention type: Device
intervention name: Non-titratable-customized mandibular advancement device
description: The most comfortable protruded mandibular position situated between 60-75% of MMPV was determined according to patient response with 6mm of the vertical interocclusal dimension between maxillary and mandibular central incisors and registered. The upper and lower acrylic resin splints were secured to each other in the posterior region with auto polymerizing acrylic resin and NTC-MADs were obtained. The patients were instructed to wear their non-titratable-customized mandibular advancement device every night.
arm group label: Mild-moderate OSA patients for MAD treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bulent Piskin, Prof.
role: Study Chair
affiliation: Technology of Dental Prosthodontics, Kapadokya University, Turkey
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: 26094920
citation: Aarab G, Lobbezoo F, Hamburger HL, Naeije M. Effects of an oral appliance with different mandibular protrusion positions at a constant vertical dimension on obstructive sleep apnea. Clin Oral Investig. 2010 Jun;14(3):339-45. doi: 10.1007/s00784-009-0298-9. Epub 2009 Jun 18.
PMID: 19536571
citation: Zhou J, Liu YH. A randomised titrated crossover study comparing two oral appliances in the treatment for mild to moderate obstructive sleep apnoea/hypopnoea syndrome. J Oral Rehabil. 2012 Dec;39(12):914-22. doi: 10.1111/joor.12006. Epub 2012 Sep 27.
PMID: 23016888
citation: Fiz JA, Jane R, Sola-Soler J, Abad J, Garcia MA, Morera J. Continuous analysis and monitoring of snores and their relationship to the apnea-hypopnea index. Laryngoscope. 2010 Apr;120(4):854-62. doi: 10.1002/lary.20815.
PMID: 20222022
citation: Umemoto G, Toyoshima H, Yamaguchi Y, Aoyagi N, Yoshimura C, Funakoshi K. Therapeutic Efficacy of Twin-Block and Fixed Oral Appliances in Patients with Obstructive Sleep Apnea Syndrome. J Prosthodont. 2019 Feb;28(2):e830-e836. doi: 10.1111/jopr.12619. Epub 2017 Apr 19.
PMID: 28422345
citation: Isacsson G, Fodor C, Sturebrand M. Obstructive sleep apnea treated with custom-made bibloc and monobloc oral appliances: a retrospective comparative study. Sleep Breath. 2017 Mar;21(1):93-100. doi: 10.1007/s11325-016-1377-1. Epub 2016 Jul 5.
PMID: 27380034
citation: Jobin V, Mayer P, Bellemare F. Predictive value of automated oxygen saturation analysis for the diagnosis and treatment of obstructive sleep apnoea in a home-based setting. Thorax. 2007 May;62(5):422-7. doi: 10.1136/thx.2006.061234. Epub 2007 Jan 24.
PMID: 17251319
citation: Ernst G, Bosio M, Salvado A, Dibur E, Nigro C, Borsini E. Difference between apnea-hypopnea index (AHI) and oxygen desaturation index (ODI): proportional increase associated with degree of obesity. Sleep Breath. 2016 Dec;20(4):1175-1183. doi: 10.1007/s11325-016-1330-3. Epub 2016 Mar 30.
PMID: 27026417
citation: Camacho M, Robertson M, Abdullatif J, Certal V, Kram YA, Ruoff CM, Brietzke SE, Capasso R. Smartphone apps for snoring. J Laryngol Otol. 2015 Oct;129(10):974-9. doi: 10.1017/S0022215115001978. Epub 2015 Sep 3.
PMID: 26333720
citation: Stippig A, Hubers U, Emerich M. Apps in sleep medicine. Sleep Breath. 2015 Mar;19(1):411-7. doi: 10.1007/s11325-014-1009-6. Epub 2014 Jun 3.
PMID: 24888483
citation: Walker-Engstrom ML, Ringqvist I, Vestling O, Wilhelmsson B, Tegelberg A. A prospective randomized study comparing two different degrees of mandibular advancement with a dental appliance in treatment of severe obstructive sleep apnea. Sleep Breath. 2003 Sep;7(3):119-30. doi: 10.1007/s11325-003-0119-3.
PMID: 14569523
citation: Lee CH, Mo JH, Choi IJ, Lee HJ, Seo BS, Kim DY, Yun PY, Yoon IY, Won Lee H, Kim JW. The mandibular advancement device and patient selection in the treatment of obstructive sleep apnea. Arch Otolaryngol Head Neck Surg. 2009 May;135(5):439-44. doi: 10.1001/archoto.2009.31.
PMID: 19451462
citation: Petri N, Svanholt P, Solow B, Wildschiodtz G, Winkel P. Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design. J Sleep Res. 2008 Jun;17(2):221-9. doi: 10.1111/j.1365-2869.2008.00645.x.
PMID: 18482111
citation: Nerfeldt P, Friberg D. Effectiveness of Oral Appliances in Obstructive Sleep Apnea with Respiratory Arousals. J Clin Sleep Med. 2016 Aug 15;12(8):1159-65. doi: 10.5664/jcsm.6058.
PMID: 27397661
responsible party type: Sponsor-Investigator
investigator affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
investigator full name: Bahadır EZMEK
investigator title: Assistant Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No