Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter

NCT04427111 | Completed

• 1 other identifier: 2015-KAEK-84
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Snoring; Obstructive sleep apnea; Mandibular advancement device; Pulse oximeter device; Smartphone sleep applications

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months

  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

  at baseline and in 6 months

Secondary Outcomes (5)

• Oxygen-desaturation index (ODI)

  at baseline and in 6 months

• Snoring index (SI)

  at baseline and in 6 months

• Simple pulse oximeter (SPO)/ODI

  at baseline and 1, 4, 12, and 24 week of MAD treatment

• Smartphone sleep application (SSA)/snoring intensity score (SIS)

  at baseline and 1, 4, 12, and 24 week of MAD treatment

• SSA/snoring percentage (SP)

  at baseline and 1, 4, 12, and 24 week of MAD treatment

Study Arms (1)

Mild-moderate OSA patients for MAD treatment

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

Device: Non-titratable-customized mandibular advancement device

Interventions

Non-titratable-customized mandibular advancement device DEVICE

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.

Mild-moderate OSA patients for MAD treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mild-moderate obstructive sleep apnea patients were referred Department of Prosthodontics, Gülhane Faculty of Dentistry for oral appliance treatment

You may qualify if:

• mild-moderate OSA patients with subjective snoring complaints

You may not qualify if:

• Severe OSA
• Undergone previous surgical therapy for SS or OSA
• High-risk of cardiovascular, respiratory, neurological, or psychiatric disorders
• Inadequate dental anchor for MAD treatment
• Temporomandibular joint dysfunction
• Angle Class III maxillomandibular relation

Sponsors & Collaborators

• Bahadır EZMEK: lead

Related Publications (14)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bulent Piskin, Prof.

  Technology of Dental Prosthodontics, Kapadokya University, Turkey

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: December 24, 2015
• Primary Completion: December 24, 2017
• Study Completion: December 24, 2017
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share